Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT00819234
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2008-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105254', 'term': 'pramlintide'}, {'id': 'C415771', 'term': 'metreleptin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Peter Ohman, Medical Science Director', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 Weeks, intent to treat population. Enrolled and treated with at least one injection during the extension study DFA102E.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.', 'otherNumAtRisk': 31, 'otherNumAffected': 20, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E', 'otherNumAtRisk': 35, 'otherNumAffected': 25, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E', 'otherNumAtRisk': 36, 'otherNumAffected': 29, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E', 'otherNumAtRisk': 28, 'otherNumAffected': 19, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.', 'otherNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.', 'otherNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.', 'otherNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.', 'otherNumAtRisk': 29, 'otherNumAffected': 26, 'seriousNumAtRisk': 29, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.', 'otherNumAtRisk': 37, 'otherNumAffected': 28, 'seriousNumAtRisk': 37, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.', 'otherNumAtRisk': 37, 'otherNumAffected': 28, 'seriousNumAtRisk': 37, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 9, 'numAffected': 7}, 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'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'injection site hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}, 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'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 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'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG001', 'title': 'Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG002', 'title': 'Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG003', 'title': 'Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.68', 'spread': '2.170', 'groupId': 'OG000', 'lowerLimit': '-7.00', 'upperLimit': '1.64'}, {'value': '-9.92', 'spread': '2.203', 'groupId': 'OG001', 'lowerLimit': '-14.30', 'upperLimit': '-5.53'}, {'value': '-9.24', 'spread': '1.944', 'groupId': 'OG002', 'lowerLimit': '-13.10', 'upperLimit': '-5.37'}, {'value': '-8.20', 'spread': '2.201', 'groupId': 'OG003', 'lowerLimit': '-12.58', 'upperLimit': '-3.82'}]}]}], 'analyses': [{'pValue': '0.0135', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.23', 'ciLowerLimit': '-12.93', 'ciUpperLimit': '-1.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.863', 'groupDescription': 'Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0168', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.55', 'ciLowerLimit': '-11.89', 'ciUpperLimit': '-1.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.681', 'groupDescription': 'Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0595', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.52', 'ciLowerLimit': '-11.27', 'ciUpperLimit': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.887', 'groupDescription': 'Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Original Study Baseline to Week 52', 'description': 'Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0.', 'unitOfMeasure': 'percentage of change in weight', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.'}, {'type': 'SECONDARY', 'title': 'LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG001', 'title': 'Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG002', 'title': 'Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG003', 'title': 'Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.'}], 'classes': [{'title': 'Week 12 (original study)', 'categories': [{'measurements': [{'value': '-4.59', 'groupId': 'OG000', 'lowerLimit': '-6.55', 'upperLimit': '-2.62'}, {'value': '-6.72', 'groupId': 'OG001', 'lowerLimit': '-8.71', 'upperLimit': '-4.73'}, {'value': '-7.31', 'groupId': 'OG002', 'lowerLimit': '-9.07', 'upperLimit': '-5.55'}, {'value': '-7.06', 'groupId': 'OG003', 'lowerLimit': '-9.05', 'upperLimit': '-5.07'}]}]}, {'title': 'Week 28 (Baseline for Extension)', 'categories': [{'measurements': [{'value': '-3.70', 'groupId': 'OG000', 'lowerLimit': '-6.74', 'upperLimit': '-0.66'}, {'value': '-8.63', 'groupId': 'OG001', 'lowerLimit': '-11.72', 'upperLimit': '-5.55'}, {'value': '-9.91', 'groupId': 'OG002', 'lowerLimit': '-12.64', 'upperLimit': '-7.19'}, {'value': '-9.46', 'groupId': 'OG003', 'lowerLimit': '-12.55', 'upperLimit': '-6.38'}]}]}, {'title': 'Week 36 in Extension Study', 'categories': [{'measurements': [{'value': '-3.53', 'groupId': 'OG000', 'lowerLimit': '-6.95', 'upperLimit': '-0.12'}, {'value': '-9.74', 'groupId': 'OG001', 'lowerLimit': '-13.21', 'upperLimit': '-6.27'}, {'value': '-10.69', 'groupId': 'OG002', 'lowerLimit': '-13.75', 'upperLimit': '-7.63'}, {'value': '-9.21', 'groupId': 'OG003', 'lowerLimit': '-12.68', 'upperLimit': '-5.75'}]}]}, {'title': 'Week 44 in Extension Study', 'categories': [{'measurements': [{'value': '-3.10', 'groupId': 'OG000', 'lowerLimit': '-6.82', 'upperLimit': '0.63'}, {'value': '-9.38', 'groupId': 'OG001', 'lowerLimit': '-13.16', 'upperLimit': '-5.60'}, {'value': '-10.00', 'groupId': 'OG002', 'lowerLimit': '-13.33', 'upperLimit': '-6.66'}, {'value': '-8.60', 'groupId': 'OG003', 'lowerLimit': '-12.38', 'upperLimit': '-4.82'}]}]}, {'title': 'Week 52 in Extension Study', 'categories': [{'measurements': [{'value': '-2.85', 'groupId': 'OG000', 'lowerLimit': '-6.98', 'upperLimit': '1.28'}, {'value': '-9.26', 'groupId': 'OG001', 'lowerLimit': '-13.45', 'upperLimit': '-5.07'}, {'value': '-9.65', 'groupId': 'OG002', 'lowerLimit': '-13.35', 'upperLimit': '-5.96'}, {'value': '-7.98', 'groupId': 'OG003', 'lowerLimit': '-12.16', 'upperLimit': '-3.79'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Original baseline to Week 52', 'description': 'Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Weeks 12 and 28 were in original study (Week 28 was baseline for extension study), while Weeks 36, 44, and 52 were in the extension study. Body weight was measured in kilograms (kg).', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.'}, {'type': 'SECONDARY', 'title': 'Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG001', 'title': 'Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG002', 'title': 'Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.'}], 'classes': [{'title': 'DFA102 Baseline', 'categories': [{'measurements': [{'value': '32.50', 'spread': '4.990', 'groupId': 'OG000'}, {'value': '34.48', 'spread': '3.089', 'groupId': 'OG001'}, {'value': '29.50', 'spread': '2.251', 'groupId': 'OG002'}]}]}, {'title': 'DFA102E Baseline (Week 28)', 'categories': [{'measurements': [{'value': '102.02', 'spread': '17.466', 'groupId': 'OG000'}, {'value': '232.48', 'spread': '29.371', 'groupId': 'OG001'}, {'value': '420.24', 'spread': '48.012', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '96.23', 'spread': '19.418', 'groupId': 'OG000'}, {'value': '236.02', 'spread': '29.856', 'groupId': 'OG001'}, {'value': '416.52', 'spread': '58.352', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '88.47', 'spread': '17.576', 'groupId': 'OG000'}, {'value': '177.32', 'spread': '25.765', 'groupId': 'OG001'}, {'value': '259.85', 'spread': '40.650', 'groupId': 'OG002'}]}]}, {'title': 'Follow up post treatment', 'categories': [{'measurements': [{'value': '52.90', 'spread': '9.584', 'groupId': 'OG000'}, {'value': '89.21', 'spread': '11.180', 'groupId': 'OG001'}, {'value': '89.49', 'spread': '11.712', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Original Study Baseline to Extension Week 52 and follow up', 'description': 'Baseline is Day 1 in original study DFA102, baseline in DFA102E is Week 28. Follow up is 3 - 28 days after the end of treatment period. As total leptin is measured, placebo arm was not included in the evaluation. Fasting total leptin is measured in nanograms per milliliter (ng/mL). The assay for measuring total plasma leptin is not specific for metreleptin and detects both endogenous leptin and exogenous metreleptin.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of metreleptin; treatment regimens same in both DFA102/DFA102E (stable population); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.'}, {'type': 'SECONDARY', 'title': 'LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}], 'classes': [{'title': 'Week 12 (original study)', 'categories': [{'measurements': [{'value': '-4.62', 'groupId': 'OG000', 'lowerLimit': '-7.15', 'upperLimit': '-2.08'}, {'value': '-4.03', 'groupId': 'OG001', 'lowerLimit': '-6.57', 'upperLimit': '-1.49'}, {'value': '-5.77', 'groupId': 'OG002', 'lowerLimit': '-8.03', 'upperLimit': '-3.51'}, {'value': '-5.70', 'groupId': 'OG003', 'lowerLimit': '-8.25', 'upperLimit': '-3.15'}]}]}, {'title': 'Week 28 (baseline in Extension study)', 'categories': [{'measurements': [{'value': '-3.37', 'groupId': 'OG000', 'lowerLimit': '-6.63', 'upperLimit': '-0.10'}, {'value': '-6.48', 'groupId': 'OG001', 'lowerLimit': '-9.75', 'upperLimit': '-3.20'}, {'value': '-7.95', 'groupId': 'OG002', 'lowerLimit': '-10.92', 'upperLimit': '-4.97'}, {'value': '-8.36', 'groupId': 'OG003', 'lowerLimit': '-11.65', 'upperLimit': '-5.07'}]}]}, {'title': 'Week 36 Extension study', 'categories': [{'measurements': [{'value': '-3.24', 'groupId': 'OG000', 'lowerLimit': '-6.77', 'upperLimit': '0.29'}, {'value': '-8.79', 'groupId': 'OG001', 'lowerLimit': '-12.33', 'upperLimit': '-5.25'}, {'value': '-9.19', 'groupId': 'OG002', 'lowerLimit': '-12.34', 'upperLimit': '-6.04'}, {'value': '-8.16', 'groupId': 'OG003', 'lowerLimit': '-11.71', 'upperLimit': '-4.60'}]}]}, {'title': 'Week 44 Extension study', 'categories': [{'measurements': [{'value': '-3.46', 'groupId': 'OG000', 'lowerLimit': '-7.20', 'upperLimit': '0.28'}, {'value': '-9.09', 'groupId': 'OG001', 'lowerLimit': '-12.74', 'upperLimit': '-5.44'}, {'value': '-9.03', 'groupId': 'OG002', 'lowerLimit': '-12.27', 'upperLimit': '-5.78'}, {'value': '-8.76', 'groupId': 'OG003', 'lowerLimit': '-12.42', 'upperLimit': '-5.10'}]}]}, {'title': 'Week 52 Extension study', 'categories': [{'measurements': [{'value': '-3.69', 'groupId': 'OG000', 'lowerLimit': '-7.43', 'upperLimit': '0.05'}, {'value': '-9.08', 'groupId': 'OG001', 'lowerLimit': '-12.95', 'upperLimit': '-5.21'}, {'value': '-9.18', 'groupId': 'OG002', 'lowerLimit': '-12.52', 'upperLimit': '-5.84'}, {'value': '-7.41', 'groupId': 'OG003', 'lowerLimit': '-11.18', 'upperLimit': '-3.65'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline is the baseline in the original study DFA102 (Day 1). If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Waist circumference was measured in centimeters (cm). Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.', 'unitOfMeasure': 'cm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'n=number of participants with non-missing waist circumference data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,26,19; Week 36 n=21,20,27,19; Week 44 n=20,20,27,19; Week 52 n=21,19,27,19.ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}], 'classes': [{'title': 'Week 12 of original study', 'categories': [{'measurements': [{'value': '-4.56', 'groupId': 'OG000', 'lowerLimit': '-6.48', 'upperLimit': '-2.65'}, {'value': '-6.93', 'groupId': 'OG001', 'lowerLimit': '-8.87', 'upperLimit': '-4.99'}, {'value': '-7.23', 'groupId': 'OG002', 'lowerLimit': '-8.95', 'upperLimit': '-5.52'}, {'value': '-7.17', 'groupId': 'OG003', 'lowerLimit': '-9.11', 'upperLimit': '-5.23'}]}]}, {'title': 'Week 28 Extension study', 'categories': [{'measurements': [{'value': '-3.78', 'groupId': 'OG000', 'lowerLimit': '-6.83', 'upperLimit': '-0.74'}, {'value': '-9.14', 'groupId': 'OG001', 'lowerLimit': '-12.22', 'upperLimit': '-6.05'}, {'value': '-9.72', 'groupId': 'OG002', 'lowerLimit': '-12.44', 'upperLimit': '-6.99'}, {'value': '-9.83', 'groupId': 'OG003', 'lowerLimit': '-12.91', 'upperLimit': '-6.74'}]}]}, {'title': 'Week 36 Extension study', 'categories': [{'measurements': [{'value': '-3.43', 'groupId': 'OG000', 'lowerLimit': '-6.91', 'upperLimit': '0.05'}, {'value': '-10.27', 'groupId': 'OG001', 'lowerLimit': '-13.80', 'upperLimit': '-6.74'}, {'value': '-10.43', 'groupId': 'OG002', 'lowerLimit': '-13.55', 'upperLimit': '-7.32'}, {'value': '-9.51', 'groupId': 'OG003', 'lowerLimit': '-13.04', 'upperLimit': '-5.98'}]}]}, {'title': 'Week 44 Extension study', 'categories': [{'measurements': [{'value': '-3.01', 'groupId': 'OG000', 'lowerLimit': '-6.86', 'upperLimit': '0.84'}, {'value': '-9.95', 'groupId': 'OG001', 'lowerLimit': '-13.86', 'upperLimit': '-6.04'}, {'value': '-9.65', 'groupId': 'OG002', 'lowerLimit': '-13.09', 'upperLimit': '-6.20'}, {'value': '-8.84', 'groupId': 'OG003', 'lowerLimit': '-12.75', 'upperLimit': '-4.94'}]}]}, {'title': 'Week 52 Extension study', 'categories': [{'measurements': [{'value': '-2.68', 'groupId': 'OG000', 'lowerLimit': '-7.00', 'upperLimit': '1.64'}, {'value': '-9.92', 'groupId': 'OG001', 'lowerLimit': '-14.30', 'upperLimit': '-5.53'}, {'value': '-9.24', 'groupId': 'OG002', 'lowerLimit': '-13.10', 'upperLimit': '-5.37'}, {'value': '-8.20', 'groupId': 'OG003', 'lowerLimit': '-12.58', 'upperLimit': '-3.82'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline is Day 1 in study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Baseline in the Extension Study was Week 28. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).', 'unitOfMeasure': 'Percentage of change in weight', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'n=number of participants with non-missing data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,27,19; Week 36 n=21,20,27,19; Week 44 n=21,20,27,19; Week 52 n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.'}, {'type': 'SECONDARY', 'title': 'LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}], 'classes': [{'title': 'glucose', 'categories': [{'measurements': [{'value': '-1.88', 'groupId': 'OG000', 'lowerLimit': '-5.62', 'upperLimit': '1.85'}, {'value': '-0.60', 'groupId': 'OG001', 'lowerLimit': '-4.36', 'upperLimit': '3.17'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '-3.38', 'upperLimit': '3.43'}, {'value': '-6.29', 'groupId': 'OG003', 'lowerLimit': '-10.07', 'upperLimit': '-2.50'}]}]}, {'title': 'total cholesterol', 'categories': [{'measurements': [{'value': '4.19', 'groupId': 'OG000', 'lowerLimit': '-8.25', 'upperLimit': '16.63'}, {'value': '-2.21', 'groupId': 'OG001', 'lowerLimit': '-15.10', 'upperLimit': '10.68'}, {'value': '-3.24', 'groupId': 'OG002', 'lowerLimit': '-14.84', 'upperLimit': '8.35'}, {'value': '-3.84', 'groupId': 'OG003', 'lowerLimit': '-17.12', 'upperLimit': '9.43'}]}]}, {'title': 'triglycerides', 'categories': [{'measurements': [{'value': '-10.05', 'groupId': 'OG000', 'lowerLimit': '-26.77', 'upperLimit': '6.67'}, {'value': '-5.41', 'groupId': 'OG001', 'lowerLimit': '-22.58', 'upperLimit': '11.76'}, {'value': '-5.86', 'groupId': 'OG002', 'lowerLimit': '-21.16', 'upperLimit': '9.43'}, {'value': '-12.74', 'groupId': 'OG003', 'lowerLimit': '-30.12', 'upperLimit': '4.64'}]}]}, {'title': 'low density lipoprotein (LDL)', 'categories': [{'measurements': [{'value': '13.43', 'groupId': 'OG000', 'lowerLimit': '1.96', 'upperLimit': '24.90'}, {'value': '4.43', 'groupId': 'OG001', 'lowerLimit': '-7.49', 'upperLimit': '16.35'}, {'value': '6.03', 'groupId': 'OG002', 'lowerLimit': '-4.64', 'upperLimit': '16.70'}, {'value': '4.43', 'groupId': 'OG003', 'lowerLimit': '-7.97', 'upperLimit': '16.82'}]}]}, {'title': 'high density lipoprotein (HDL)', 'categories': [{'measurements': [{'value': '2.92', 'groupId': 'OG000', 'lowerLimit': '-0.36', 'upperLimit': '6.21'}, {'value': '7.96', 'groupId': 'OG001', 'lowerLimit': '4.57', 'upperLimit': '11.36'}, {'value': '5.04', 'groupId': 'OG002', 'lowerLimit': '2.01', 'upperLimit': '8.08'}, {'value': '7.61', 'groupId': 'OG003', 'lowerLimit': '4.10', 'upperLimit': '11.12'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Glucose, total cholesterol, triglycerides, low density lipoprotein (LDL), and high density lipoprotein (HDL) were measured in milligrams per deciliter (mg/dL). Baseline was Day 1 in original study DFA102, Week 52 was in extension study DFA102E. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'n=number of participants with non-missing data in each treatment group by test. glucose n=20,20,27,19; total cholesterol n=21,20,27,19; triglycerides n=21,20,27,19; LDL/HDL n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E (stable); completed Week 52; no major protocol deviations in DFA102 or DFA102E.'}, {'type': 'SECONDARY', 'title': 'LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'groupId': 'OG000', 'lowerLimit': '-2.97', 'upperLimit': '1.89'}, {'value': '-2.16', 'groupId': 'OG001', 'lowerLimit': '-4.71', 'upperLimit': '0.39'}, {'value': '-0.62', 'groupId': 'OG002', 'lowerLimit': '-2.94', 'upperLimit': '1.70'}, {'value': '-1.61', 'groupId': 'OG003', 'lowerLimit': '-4.20', 'upperLimit': '0.97'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 52', 'description': 'Total insulin was measured in micro international units per milliliter (µIU/mL). Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).', 'unitOfMeasure': 'µIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'n=number of participants with non-missing data in each treatment group. ITT population (received at least 1 injection) with treatment regimens same in DFA102/DFA102E (stable treatment); completed Week 52; no major protocol deviations in DFA102/102E.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'title': 'Weight Loss >=5% and <10%', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}]}]}, {'title': 'Weight Loss >=10% and <15%', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}]}, {'title': 'Weight Loss >=5%', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '18', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}]}]}, {'title': 'Weight Loss >=10%', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}]}, {'title': 'Weight Loss >=15%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Percent change in body weight from baseline was categorized: Change greater than (\\>) 0% (Body weight gain); Change less than, equal to (\\<=) 0 to \\> -5% (No body weight change or body weight loss \\<5%); Change \\<= -5% (Body weight loss greater than, equal to (\\>=)5%); Change \\<= -5% to \\> -10% (Body weight loss \\>=5% and \\<10%); Change \\<= -10% (Body weight loss ≥10%); Change \\<= -10% to \\> -15% (Body weight loss \\>=10% and \\<15%); Change \\<= -15% (Body weight loss \\>=15%).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed with non-missing data at Week 52. Week 52 Evaluable Population: All ITT participants (received at least 1 injection);remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock);no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'title': 'Weight Loss >=5% and <10%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}]}, {'title': 'Weight Loss >=10% and <15%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'Weight Loss >=5%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}]}]}, {'title': 'Weight Loss >=10%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'Weight Loss >=15%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 28) to Week 52', 'description': 'Baseline in extension study was Week 28; if value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Percent change in body weight from baseline was categorized: Change greater than (\\>) 0% (Body weight gain); Change less than, equal to (\\<=) 0 to \\> -5% (No body weight change or body weight loss \\<5%); Change \\<= -5% (Body weight loss greater than, equal to (\\>=)5%); Change \\<= -5% to \\> -10% (Body weight loss \\>=5% and \\<10%); Change \\<= -10% (Body weight loss ≥10%); Change \\<= -10% to \\> -15% (Body weight loss \\>=10% and \\<15%); Change \\<= -15% (Body weight loss \\>=15%).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed had non-missing data at Week 52. Week 52 Evaluable Population: ITT participants (received at least 1 injection); remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock); no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.'}, {'type': 'SECONDARY', 'title': 'Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Week 52 Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'title': 'Frequency of Food Cravings', 'categories': [{'measurements': [{'value': '-14.1', 'spread': '16.91', 'groupId': 'OG000'}, {'value': '-14.4', 'spread': '18.61', 'groupId': 'OG001'}, {'value': '-15.0', 'spread': '23.59', 'groupId': 'OG002'}, {'value': '-21.4', 'spread': '33.81', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '19.21', 'groupId': 'OG004'}, {'value': '-22.6', 'spread': '33.53', 'groupId': 'OG005'}, {'value': '-13.7', 'spread': '41.94', 'groupId': 'OG006'}, {'value': '-18.9', 'spread': '21.06', 'groupId': 'OG007'}, {'value': '-12.8', 'spread': '21.82', 'groupId': 'OG008'}, {'value': '-21.4', 'spread': '25.56', 'groupId': 'OG009'}]}]}, {'title': 'Strength of Food Cravings', 'categories': [{'measurements': [{'value': '-14.3', 'spread': '15.48', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '22.96', 'groupId': 'OG001'}, {'value': '-14.2', 'spread': '22.26', 'groupId': 'OG002'}, {'value': '-17.9', 'spread': '28.54', 'groupId': 'OG003'}, {'value': '5.3', 'spread': '19.35', 'groupId': 'OG004'}, {'value': '-30.3', 'spread': '30.57', 'groupId': 'OG005'}, {'value': '-9.5', 'spread': '32.57', 'groupId': 'OG006'}, {'value': '-13.0', 'spread': '28.56', 'groupId': 'OG007'}, {'value': '-8.8', 'spread': '25.08', 'groupId': 'OG008'}, {'value': '-14.6', 'spread': '22.39', 'groupId': 'OG009'}]}]}, {'title': 'Difficult to Control Eating', 'categories': [{'measurements': [{'value': '-18.3', 'spread': '25.17', 'groupId': 'OG000'}, {'value': '-19.7', 'spread': '20.36', 'groupId': 'OG001'}, {'value': '-23.3', 'spread': '27.38', 'groupId': 'OG002'}, {'value': '-17.6', 'spread': '28.98', 'groupId': 'OG003'}, {'value': '-8.8', 'spread': '19.64', 'groupId': 'OG004'}, {'value': '-31.6', 'spread': '29.38', 'groupId': 'OG005'}, {'value': '-17.7', 'spread': '27.47', 'groupId': 'OG006'}, {'value': '-22.1', 'spread': '22.64', 'groupId': 'OG007'}, {'value': '-16.6', 'spread': '24.54', 'groupId': 'OG008'}, {'value': '-28.7', 'spread': '23.15', 'groupId': 'OG009'}]}]}, {'title': 'Difficult to Resist Food Cravings', 'categories': [{'measurements': [{'value': '-17.6', 'spread': '25.36', 'groupId': 'OG000'}, {'value': '-20.0', 'spread': '23.08', 'groupId': 'OG001'}, {'value': '-24.2', 'spread': '25.77', 'groupId': 'OG002'}, {'value': '-16.9', 'spread': '30.90', 'groupId': 'OG003'}, {'value': '-3.0', 'spread': '20.43', 'groupId': 'OG004'}, {'value': '-30.9', 'spread': '31.20', 'groupId': 'OG005'}, {'value': '-15.7', 'spread': '36.47', 'groupId': 'OG006'}, {'value': '-25.6', 'spread': '22.32', 'groupId': 'OG007'}, {'value': '-18.5', 'spread': '23.65', 'groupId': 'OG008'}, {'value': '-25.8', 'spread': '26.29', 'groupId': 'OG009'}]}]}, {'title': 'Eating in Response to Food Cravings', 'categories': [{'measurements': [{'value': '-18.4', 'spread': '31.97', 'groupId': 'OG000'}, {'value': '-18.7', 'spread': '26.60', 'groupId': 'OG001'}, {'value': '-20.4', 'spread': '22.96', 'groupId': 'OG002'}, {'value': '-21.3', 'spread': '30.83', 'groupId': 'OG003'}, {'value': '-1.8', 'spread': '20.91', 'groupId': 'OG004'}, {'value': '-26.6', 'spread': '32.46', 'groupId': 'OG005'}, {'value': '-7.3', 'spread': '30.61', 'groupId': 'OG006'}, {'value': '-27.4', 'spread': '17.41', 'groupId': 'OG007'}, {'value': '-13.4', 'spread': '22.50', 'groupId': 'OG008'}, {'value': '-29.2', 'spread': '26.61', 'groupId': 'OG009'}]}]}, {'title': 'Difficult to Control Portion Sizes', 'categories': [{'measurements': [{'value': '-24.6', 'spread': '25.85', 'groupId': 'OG000'}, {'value': '-19.9', 'spread': '21.13', 'groupId': 'OG001'}, {'value': '-25.0', 'spread': '25.80', 'groupId': 'OG002'}, {'value': '-31.7', 'spread': '30.85', 'groupId': 'OG003'}, {'value': '-6.6', 'spread': '25.50', 'groupId': 'OG004'}, {'value': '-24.4', 'spread': '26.68', 'groupId': 'OG005'}, {'value': '-11.5', 'spread': '23.42', 'groupId': 'OG006'}, {'value': '-33.1', 'spread': '20.46', 'groupId': 'OG007'}, {'value': '-24.4', 'spread': '21.62', 'groupId': 'OG008'}, {'value': '-27.4', 'spread': '24.34', 'groupId': 'OG009'}]}]}, {'title': 'How Hungry', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '20.40', 'groupId': 'OG000'}, {'value': '-12.8', 'spread': '19.31', 'groupId': 'OG001'}, {'value': '-20.3', 'spread': '23.23', 'groupId': 'OG002'}, {'value': '-12.9', 'spread': '29.00', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '25.54', 'groupId': 'OG004'}, {'value': '-17.9', 'spread': '12.13', 'groupId': 'OG005'}, {'value': '-5.0', 'spread': '20.61', 'groupId': 'OG006'}, {'value': '-20.8', 'spread': '26.63', 'groupId': 'OG007'}, {'value': '-8.2', 'spread': '25.80', 'groupId': 'OG008'}, {'value': '-16.2', 'spread': '28.58', 'groupId': 'OG009'}]}]}, {'title': 'How Full After Meals', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '33.57', 'groupId': 'OG000'}, {'value': '-10.1', 'spread': '22.03', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '24.74', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '29.96', 'groupId': 'OG003'}, {'value': '0.8', 'spread': '24.77', 'groupId': 'OG004'}, {'value': '-4.3', 'spread': '44.84', 'groupId': 'OG005'}, {'value': '11.8', 'spread': '21.18', 'groupId': 'OG006'}, {'value': '-6.2', 'spread': '23.42', 'groupId': 'OG007'}, {'value': '-1.3', 'spread': '20.86', 'groupId': 'OG008'}, {'value': '-10.2', 'spread': '27.99', 'groupId': 'OG009'}]}]}, {'title': 'Thoughts of Food', 'categories': [{'measurements': [{'value': '-8.5', 'spread': '17.01', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '16.06', 'groupId': 'OG001'}, {'value': '-17.9', 'spread': '22.54', 'groupId': 'OG002'}, {'value': '-17.4', 'spread': '32.05', 'groupId': 'OG003'}, {'value': '-1.5', 'spread': '29.05', 'groupId': 'OG004'}, {'value': '-26.3', 'spread': '22.97', 'groupId': 'OG005'}, {'value': '-14.5', 'spread': '44.56', 'groupId': 'OG006'}, {'value': '-16.3', 'spread': '22.70', 'groupId': 'OG007'}, {'value': '-6.0', 'spread': '22.34', 'groupId': 'OG008'}, {'value': '-18.4', 'spread': '24.90', 'groupId': 'OG009'}]}]}, {'title': 'How Pleasant Meals', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '17.16', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '22.85', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '24.09', 'groupId': 'OG002'}, {'value': '15.5', 'spread': '30.30', 'groupId': 'OG003'}, {'value': '8.8', 'spread': '21.84', 'groupId': 'OG004'}, {'value': '8.4', 'spread': '16.00', 'groupId': 'OG005'}, {'value': '7.7', 'spread': '13.09', 'groupId': 'OG006'}, {'value': '7.1', 'spread': '17.29', 'groupId': 'OG007'}, {'value': '1.3', 'spread': '20.91', 'groupId': 'OG008'}, {'value': '-5.2', 'spread': '24.10', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening to Week 52', 'description': 'The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 items, with each response measured on a 100 mm visual analogue scale (VAS). Ranges vary from: Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores show improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.'}, {'type': 'SECONDARY', 'title': 'Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - Week 52 Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '4.60', 'groupId': 'OG001'}, {'value': '-7.1', 'spread': '7.31', 'groupId': 'OG002'}, {'value': '-7.4', 'spread': '7.90', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '7.98', 'groupId': 'OG004'}, {'value': '-10.4', 'spread': '7.98', 'groupId': 'OG005'}, {'value': '-8.6', 'spread': '2.41', 'groupId': 'OG006'}, {'value': '-8.1', 'spread': '4.92', 'groupId': 'OG007'}, {'value': '-5.3', 'spread': '7.97', 'groupId': 'OG008'}, {'value': '-8.1', 'spread': '8.22', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening to Week 52', 'description': "The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Lower scores show improvement. The minimum and maximum score for the BES instrument is 0 and 55, respectively; the higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.'}, {'type': 'SECONDARY', 'title': 'Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total Scores - Week 52 Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '37', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'title': 'Change in Total Scores for Anxiety', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.33', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '2.84', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '3.42', 'groupId': 'OG003'}, {'value': '-0.8', 'spread': '3.31', 'groupId': 'OG004'}, {'value': '0.1', 'spread': '2.11', 'groupId': 'OG005'}, {'value': '0.4', 'spread': '1.43', 'groupId': 'OG006'}, {'value': '-0.7', 'spread': '2.69', 'groupId': 'OG007'}, {'value': '-1.2', 'spread': '3.45', 'groupId': 'OG008'}, {'value': '-0.8', 'spread': '3.00', 'groupId': 'OG009'}]}]}, {'title': 'Change in Total Scores for Depression', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.60', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.70', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '2.85', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '2.66', 'groupId': 'OG004'}, {'value': '-1.0', 'spread': '2.80', 'groupId': 'OG005'}, {'value': '-0.8', 'spread': '2.44', 'groupId': 'OG006'}, {'value': '-1.3', 'spread': '2.59', 'groupId': 'OG007'}, {'value': '-0.9', 'spread': '2.26', 'groupId': 'OG008'}, {'value': '-1.7', 'spread': '2.57', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening to Week 52', 'description': 'The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.'}, {'type': 'SECONDARY', 'title': 'Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score - Week 52 Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '3.17', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '3.13', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '3.28', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '4.41', 'groupId': 'OG004'}, {'value': '-3.9', 'spread': '3.18', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '1.67', 'groupId': 'OG006'}, {'value': '-1.3', 'spread': '3.34', 'groupId': 'OG007'}, {'value': '-1.2', 'spread': '2.42', 'groupId': 'OG008'}, {'value': '-1.1', 'spread': '4.15', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening to Week 52', 'description': 'The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.'}, {'type': 'SECONDARY', 'title': 'Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG001', 'title': 'Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG002', 'title': 'Pramlintide 360 Mcg + Metreleptin 5 mg - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}], 'classes': [{'title': 'Baseline in DFA102 (Day 1)', 'categories': [{'measurements': [{'value': '32.50', 'spread': '4.990', 'groupId': 'OG000'}, {'value': '34.48', 'spread': '3.089', 'groupId': 'OG001'}, {'value': '29.50', 'spread': '2.251', 'groupId': 'OG002'}]}]}, {'title': 'Baseline in DFA102E (Week 28)', 'categories': [{'measurements': [{'value': '102.02', 'spread': '17.466', 'groupId': 'OG000'}, {'value': '232.48', 'spread': '29.371', 'groupId': 'OG001'}, {'value': '420.24', 'spread': '48.012', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '96.23', 'spread': '19.418', 'groupId': 'OG000'}, {'value': '236.02', 'spread': '29.856', 'groupId': 'OG001'}, {'value': '416.52', 'spread': '58.352', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '88.47', 'spread': '17.576', 'groupId': 'OG000'}, {'value': '177.32', 'spread': '25.765', 'groupId': 'OG001'}, {'value': '259.85', 'spread': '40.650', 'groupId': 'OG002'}]}]}, {'title': 'Follow up after end of treatment', 'categories': [{'measurements': [{'value': '52.90', 'spread': '9.584', 'groupId': 'OG000'}, {'value': '89.21', 'spread': '11.180', 'groupId': 'OG001'}, {'value': '89.49', 'spread': '11.712', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to end of treatment follow up', 'description': 'Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1 in DFA102 study and Week 28 in study DFA102E. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred 3-28 days after end of treatment. Leptin concentrations were measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. Week 52 Stable Evaluable: Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'number (n) of participants who are Week 52 evaluable in a stable treatment sequence (received the same treatment in both DFA102 and DFA102E) and who had follow up data. Week 52 in Metreleptin 2.5 mg arm n=55 (all others n=56); Week 40 in Metreleptin 5 mg arm n=66 (all others n=68)'}, {'type': 'SECONDARY', 'title': 'Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '12.74', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '14.54', 'groupId': 'OG002'}, {'value': '-4.9', 'spread': '10.88', 'groupId': 'OG003'}, {'value': '0.7', 'spread': '14.57', 'groupId': 'OG004'}, {'value': '3.7', 'spread': '14.35', 'groupId': 'OG005'}, {'value': '-6.4', 'spread': '6.21', 'groupId': 'OG006'}, {'value': '-2.9', 'spread': '9.75', 'groupId': 'OG007'}, {'value': '-7.0', 'spread': '9.63', 'groupId': 'OG008'}, {'value': '-4.8', 'spread': '10.94', 'groupId': 'OG009'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '5.40', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '9.17', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '7.29', 'groupId': 'OG002'}, {'value': '-1.5', 'spread': '9.98', 'groupId': 'OG003'}, {'value': '-1.7', 'spread': '8.56', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '7.74', 'groupId': 'OG005'}, {'value': '-5.3', 'spread': '8.94', 'groupId': 'OG006'}, {'value': '-5.8', 'spread': '8.17', 'groupId': 'OG007'}, {'value': '-2.5', 'spread': '9.77', 'groupId': 'OG008'}, {'value': '-4.0', 'spread': '5.99', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment; had data available.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '9.22', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '9.39', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '6.49', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '7.73', 'groupId': 'OG003'}, {'value': '-1.6', 'spread': '5.81', 'groupId': 'OG004'}, {'value': '0.9', 'spread': '9.25', 'groupId': 'OG005'}, {'value': '-0.9', 'spread': '11.75', 'groupId': 'OG006'}, {'value': '-2.6', 'spread': '8.39', 'groupId': 'OG007'}, {'value': '-4.0', 'spread': '7.12', 'groupId': 'OG008'}, {'value': '-2.8', 'spread': '6.58', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm).', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment; had data available.'}, {'type': 'SECONDARY', 'title': 'Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'title': 'PR Interval', 'categories': [{'measurements': [{'value': '1.2', 'spread': '10.29', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '22.15', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '14.11', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '13.14', 'groupId': 'OG003'}, {'value': '15.8', 'spread': '52.77', 'groupId': 'OG004'}, {'value': '6.0', 'spread': '8.49', 'groupId': 'OG005'}, {'value': '2.5', 'spread': '9.50', 'groupId': 'OG006'}, {'value': '-2.3', 'spread': '10.83', 'groupId': 'OG007'}, {'value': '1.8', 'spread': '13.80', 'groupId': 'OG008'}, {'value': '0.9', 'spread': '10.82', 'groupId': 'OG009'}]}]}, {'title': 'QRS', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '5.19', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '11.05', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '6.81', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '5.76', 'groupId': 'OG003'}, {'value': '-2.4', 'spread': '14.09', 'groupId': 'OG004'}, {'value': '1.6', 'spread': '4.24', 'groupId': 'OG005'}, {'value': '0.0', 'spread': '9.56', 'groupId': 'OG006'}, {'value': '1.7', 'spread': '5.50', 'groupId': 'OG007'}, {'value': '0.5', 'spread': '6.15', 'groupId': 'OG008'}, {'value': '-0.9', 'spread': '4.35', 'groupId': 'OG009'}]}]}, {'title': 'QT Interval', 'categories': [{'measurements': [{'value': '15.3', 'spread': '28.67', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '32.50', 'groupId': 'OG001'}, {'value': '15.6', 'spread': '22.54', 'groupId': 'OG002'}, {'value': '8.2', 'spread': '26.37', 'groupId': 'OG003'}, {'value': '19.4', 'spread': '18.57', 'groupId': 'OG004'}, {'value': '13.3', 'spread': '25.00', 'groupId': 'OG005'}, {'value': '2.5', 'spread': '23.10', 'groupId': 'OG006'}, {'value': '14.4', 'spread': '31.39', 'groupId': 'OG007'}, {'value': '5.5', 'spread': '20.21', 'groupId': 'OG008'}, {'value': '16.7', 'spread': '16.94', 'groupId': 'OG009'}]}]}, {'title': 'QTcF', 'categories': [{'measurements': [{'value': '1.3', 'spread': '22.08', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '16.64', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '16.69', 'groupId': 'OG002'}, {'value': '-2.2', 'spread': '18.96', 'groupId': 'OG003'}, {'value': '7.1', 'spread': '11.66', 'groupId': 'OG004'}, {'value': '5.1', 'spread': '24.22', 'groupId': 'OG005'}, {'value': '6.5', 'spread': '15.19', 'groupId': 'OG006'}, {'value': '3.2', 'spread': '24.49', 'groupId': 'OG007'}, {'value': '-1.7', 'spread': '16.34', 'groupId': 'OG008'}, {'value': '0.8', 'spread': '16.23', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening to Week 52', 'description': "A 12-Lead electrocardiogram (ECG) was obtained. The PR interval, which is the time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval, which is time from the beginning to the end of the QRS complex; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).", 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment; had ECG data available at Week 52.'}, {'type': 'SECONDARY', 'title': 'Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'title': 'Hematocrit', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Platelet Count', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'WBC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Urinalysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline defined as Week 28 (first week of study DFA102E). Hematology: Hematocrit males \\<36%, females \\<30%. Hemoglobin males \\<12 g/dL, females \\<10 g/dL. White blood cell count (WBC) H \\>18,000/µL; L \\<1,500/µL. Urinalysis: Urine protein H \\>= 3+ or \\>= 500 mg/dL. Urine glucose H \\>= 3+ or \\>= 500 mg/dL. Urine ketones \\>= 3+ or Large. Laboratory values were obtained at Weeks 28, 36, 44, and 52. Numbers of values are cumulative across the extension', 'unitOfMeasure': 'number of laboratory values', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and received at least 1 injection of any treatment; participants had laboratory data available; platelet counts: n=19 in second arm (not 20); n=20 in fourth arm (not 22); n=11 in fifth arm (not 12);'}, {'type': 'SECONDARY', 'title': 'Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'OG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'classes': [{'title': 'alanine aminotransferase (ALT)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Bicarbonate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Creatine kinase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Calcium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Gamma-glutamyltransferase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Potassium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Sodium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Uric Acid', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline defined in study DFA102E as Week 28. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI\\>=25 kg/m\\^2) participants: Total bilirubin High (H) \\> 2 mg/dL; Plasma or serum glucose fasting or non-fasting H \\> 200 mg/dL, low (L) \\< 60 mg/dL; Albumin L \\<2.5 g/dL; Creatine kinase H \\> 3\\*Upper limit of Normal (ULN); Sodium L \\<130 milliequivalents per liter (mEq/L), H \\> 150 mEq/L; potassium L\\<3.0 mEq/L, H\\> 5.5 mEq/L;bicarbonate L\\<18 mEq/L, H\\>35 mEq/L;calcium L \\<8mg/dL, H\\> 11 mg/dL; triglycerides H\\> 500 mg/dL; Cholesterol L \\< 100 mg/dL, H \\> 350 mg/dL; Alkaline phosphatase H \\> 3\\*ULN; Gamma-glutamyltransferase H\\>3\\*ULN; creatinine males \\> 1.6 mg/dL, females \\> 1.4 mg/dL; alanine aminotransferase H \\> 3\\*ULN; aspartate aminotransferase H \\> 3\\*ULN; urea nitrogen H \\> 45 mg/dL; uric acid males \\> 10.0 mg/dL, females \\> 8.0 mg/dL; Phosphorus L \\< 1.0 mg/dL H \\> 6.0 mg/dL. Laboratory values obtained at Weeks 28, 36, 44, and 52; number of values a', 'unitOfMeasure': 'Number of Laboratory values', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled participants who received at least one injection of any study medication in Study DFA102E; had laboratory data available. Number analyzed presented above is at Week 52; Number analyzed at Week 28: N= 31, 35, 36, 28, 13, 14, 13, 29, 37, 37.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '360 mcg Pramlintide + Metreleptin 1.25 mg - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG001', 'title': '360 mcg Pramlintide + Metreleptin 2.5 mg - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG002', 'title': '360 mcg Pramlintide + Metreleptin 5 mg - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'OG003', 'title': '360 mcg Pramlintide + Metreleptin 1.25 mg - Prior Monotherapy', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG004', 'title': '360 mcg Pramlintide + Metreleptin 2.5 mg - Prior Monotherapy', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'OG005', 'title': '360 mcg Pramlintide + Metreleptin 5 mg - Prior Monotherapy', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.'}], 'classes': [{'title': 'Week 52', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'Follow up after end of treatment', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of treatment follow up', 'description': 'Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred on Days 3 - 28 after treatment ended. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer \\>=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'N for Week 52 presented above. For Follow up: N=18,58,68,11,7,8.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo - Stable', 'description': 'Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'FG001', 'title': '360 mcg Pramlintide + 1.25mg Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'FG002', 'title': '360 mcg Pramlintide + 2.5 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E'}, {'id': 'FG003', 'title': '360 mcg Pramlintide + 5.0 Metreleptin - Stable', 'description': 'Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.\n\nStable: same treatment regimen in both DFA102 and DFA102E.'}, {'id': 'FG004', 'title': '360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Monotherapy', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'FG005', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Monotherapy', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'FG006', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Monotherapy', 'description': 'Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.'}, {'id': 'FG007', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono', 'description': 'Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'FG008', 'title': '360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}, {'id': 'FG009', 'title': '360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram', 'description': 'Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '13'}, {'groupId': 'FG007', 'numSubjects': '29'}, {'groupId': 'FG008', 'numSubjects': '37'}, {'groupId': 'FG009', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '31'}, {'groupId': 'FG009', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants (overweight and obese) must have been randomized and treated in original DFA102 Study (NCT00673387) in order to be enrolled into this extension study DFA102E and followed for a total of up to 52 weeks, inclusive of DFA102 (ie, DFA102 and DFA102E studies together have a total length of 52 weeks).', 'preAssignmentDetails': 'DFA102 participants assigned to: placebo, 360mcg pramlintide+1.25mg metreleptin, 360mcg pram+2.5mg metre, or 360mcg pram+5.0mg metre did not change treatment in extension (stable groups). All other groups transitioned to 360mcg pram + 1.25, 2.5 or 5.0mg metre. 274 enrolled in extension and 273 were treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants who completed the original study and chose to enter the extension study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '10.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '191', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '95.83', 'spread': '17.007', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline in the extension study was Week 28 in the original study. If Week 28 value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI) at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '34.16', 'spread': '4.988', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline refers to Week 28 in original study. If Week 28 was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Body Mass Index (BMI) was measured as kilogram per meter of height squared (kg/m\\^2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants who completed original study and chose to be enrolled into this extension study and were treated with study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-26', 'studyFirstSubmitDate': '2008-12-24', 'resultsFirstSubmitDate': '2013-08-12', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-13', 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population', 'timeFrame': 'Original Study Baseline to Week 52', 'description': 'Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0.'}], 'secondaryOutcomes': [{'measure': 'LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population', 'timeFrame': 'Original baseline to Week 52', 'description': 'Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Weeks 12 and 28 were in original study (Week 28 was baseline for extension study), while Weeks 36, 44, and 52 were in the extension study. Body weight was measured in kilograms (kg).'}, {'measure': 'Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population', 'timeFrame': 'Original Study Baseline to Extension Week 52 and follow up', 'description': 'Baseline is Day 1 in original study DFA102, baseline in DFA102E is Week 28. Follow up is 3 - 28 days after the end of treatment period. As total leptin is measured, placebo arm was not included in the evaluation. Fasting total leptin is measured in nanograms per milliliter (ng/mL). The assay for measuring total plasma leptin is not specific for metreleptin and detects both endogenous leptin and exogenous metreleptin.'}, {'measure': 'LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline is the baseline in the original study DFA102 (Day 1). If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Waist circumference was measured in centimeters (cm). Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.'}, {'measure': 'LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline is Day 1 in study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Baseline in the Extension Study was Week 28. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).'}, {'measure': 'LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Glucose, total cholesterol, triglycerides, low density lipoprotein (LDL), and high density lipoprotein (HDL) were measured in milligrams per deciliter (mg/dL). Baseline was Day 1 in original study DFA102, Week 52 was in extension study DFA102E. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).'}, {'measure': 'LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population', 'timeFrame': 'Baseline to Week 52', 'description': 'Total insulin was measured in micro international units per milliliter (µIU/mL). Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).'}, {'measure': 'Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Percent change in body weight from baseline was categorized: Change greater than (\\>) 0% (Body weight gain); Change less than, equal to (\\<=) 0 to \\> -5% (No body weight change or body weight loss \\<5%); Change \\<= -5% (Body weight loss greater than, equal to (\\>=)5%); Change \\<= -5% to \\> -10% (Body weight loss \\>=5% and \\<10%); Change \\<= -10% (Body weight loss ≥10%); Change \\<= -10% to \\> -15% (Body weight loss \\>=10% and \\<15%); Change \\<= -15% (Body weight loss \\>=15%).'}, {'measure': 'Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population', 'timeFrame': 'Baseline (Week 28) to Week 52', 'description': 'Baseline in extension study was Week 28; if value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Percent change in body weight from baseline was categorized: Change greater than (\\>) 0% (Body weight gain); Change less than, equal to (\\<=) 0 to \\> -5% (No body weight change or body weight loss \\<5%); Change \\<= -5% (Body weight loss greater than, equal to (\\>=)5%); Change \\<= -5% to \\> -10% (Body weight loss \\>=5% and \\<10%); Change \\<= -10% (Body weight loss ≥10%); Change \\<= -10% to \\> -15% (Body weight loss \\>=10% and \\<15%); Change \\<= -15% (Body weight loss \\>=15%).'}, {'measure': 'Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Week 52 Evaluable Population', 'timeFrame': 'Screening to Week 52', 'description': 'The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 items, with each response measured on a 100 mm visual analogue scale (VAS). Ranges vary from: Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores show improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.'}, {'measure': 'Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - Week 52 Evaluable Population', 'timeFrame': 'Screening to Week 52', 'description': "The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Lower scores show improvement. The minimum and maximum score for the BES instrument is 0 and 55, respectively; the higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E."}, {'measure': 'Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total Scores - Week 52 Evaluable Population', 'timeFrame': 'Screening to Week 52', 'description': 'The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.'}, {'measure': 'Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score - Week 52 Evaluable Population', 'timeFrame': 'Screening to Week 52', 'description': 'The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.'}, {'measure': 'Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population', 'timeFrame': 'Baseline to end of treatment follow up', 'description': 'Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1 in DFA102 study and Week 28 in study DFA102E. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred 3-28 days after end of treatment. Leptin concentrations were measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. Week 52 Stable Evaluable: Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.'}, {'measure': 'Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population', 'timeFrame': 'Baseline (Day 1) to Week 52', 'description': 'Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg).'}, {'measure': 'Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm).'}, {'measure': 'Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population', 'timeFrame': 'Screening to Week 52', 'description': "A 12-Lead electrocardiogram (ECG) was obtained. The PR interval, which is the time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval, which is time from the beginning to the end of the QRS complex; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec)."}, {'measure': 'Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline defined as Week 28 (first week of study DFA102E). Hematology: Hematocrit males \\<36%, females \\<30%. Hemoglobin males \\<12 g/dL, females \\<10 g/dL. White blood cell count (WBC) H \\>18,000/µL; L \\<1,500/µL. Urinalysis: Urine protein H \\>= 3+ or \\>= 500 mg/dL. Urine glucose H \\>= 3+ or \\>= 500 mg/dL. Urine ketones \\>= 3+ or Large. Laboratory values were obtained at Weeks 28, 36, 44, and 52. Numbers of values are cumulative across the extension'}, {'measure': 'Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population', 'timeFrame': 'Baseline to Week 52', 'description': 'Baseline defined in study DFA102E as Week 28. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI\\>=25 kg/m\\^2) participants: Total bilirubin High (H) \\> 2 mg/dL; Plasma or serum glucose fasting or non-fasting H \\> 200 mg/dL, low (L) \\< 60 mg/dL; Albumin L \\<2.5 g/dL; Creatine kinase H \\> 3\\*Upper limit of Normal (ULN); Sodium L \\<130 milliequivalents per liter (mEq/L), H \\> 150 mEq/L; potassium L\\<3.0 mEq/L, H\\> 5.5 mEq/L;bicarbonate L\\<18 mEq/L, H\\>35 mEq/L;calcium L \\<8mg/dL, H\\> 11 mg/dL; triglycerides H\\> 500 mg/dL; Cholesterol L \\< 100 mg/dL, H \\> 350 mg/dL; Alkaline phosphatase H \\> 3\\*ULN; Gamma-glutamyltransferase H\\>3\\*ULN; creatinine males \\> 1.6 mg/dL, females \\> 1.4 mg/dL; alanine aminotransferase H \\> 3\\*ULN; aspartate aminotransferase H \\> 3\\*ULN; urea nitrogen H \\> 45 mg/dL; uric acid males \\> 10.0 mg/dL, females \\> 8.0 mg/dL; Phosphorus L \\< 1.0 mg/dL H \\> 6.0 mg/dL. Laboratory values obtained at Weeks 28, 36, 44, and 52; number of values a'}, {'measure': 'Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population', 'timeFrame': 'Baseline to end of treatment follow up', 'description': 'Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred on Days 3 - 28 after treatment ended. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer \\>=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Leptin', 'Pramlintide', 'Obese', 'Symlin', 'Amylin'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '26589105', 'type': 'DERIVED', 'citation': 'Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ. Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy. Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980. Epub 2016 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations\n* Male, or female and meets all the following criteria:\n\n 1. Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)\n 2. If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study\n* Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements\n\nExclusion Criteria:\n\n* Is expected to require or undergo treatment with any exclusionary medication.\n* Is undesirable as a study participant as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT00819234', 'briefTitle': 'Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin in Obese and Overweight Subjects', 'orgStudyIdInfo': {'id': 'DFA102E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Pramlintide and 1.25mg Metreleptin', 'interventionNames': ['Drug: Pramlintide and Metreleptin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Pramlintide and 2.5mg Metreleptin', 'interventionNames': ['Drug: Pramlintide and Metreleptin']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Pramlintide and 5.0mg Metreleptin', 'interventionNames': ['Drug: Pramlintide and Metreleptin']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo pramlintide and placebo metreleptin twice daily', 'armGroupLabels': ['1']}, {'name': 'Pramlintide and Metreleptin', 'type': 'DRUG', 'otherNames': ['Symlin'], 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