Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 2:20 AM
Study NCT ID:
NCT04455633
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medical-information@lexpharma.com', 'phone': '510-338-6064', 'title': 'Medical Affairs', 'organization': 'Lexicon Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable participant matter.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug after randomization up to the end of study (up to Week 11)', 'description': 'The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \\>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Double-blind Treatment Period)', 'description': 'Following a 2-week single-blind Run-in period, participants were randomized to receive a single loading dose of LX9211 matching placebo tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 9, 'seriousNumAtRisk': 107, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'LX9211 100 mg/10 mg (Double-blind Treatment Period)', 'description': 'Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 100 mg tablet, orally, on Day 1 and maintenance doses of 10 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 39, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'LX9211 200 mg/20 mg (Double-blind Treatment Period)', 'description': 'Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 44, 'seriousNumAtRisk': 106, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo (Single-blind Follow-up Period)', 'description': 'Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 4, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'LX9211 100 mg/10 mg (Single-blind Follow-up Period)', 'description': 'Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 2, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'LX9211 200 mg/20 mg Single-blind Follow-up Period)', 'description': 'Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 6, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Orthopnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.'}, {'id': 'OG001', 'title': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'OG002', 'title': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.72', 'groupId': 'OG000', 'lowerLimit': '-1.08', 'upperLimit': '-0.36'}, {'value': '-1.39', 'groupId': 'OG001', 'lowerLimit': '-1.77', 'upperLimit': '-1.01'}, {'value': '-1.27', 'groupId': 'OG002', 'lowerLimit': '-1.66', 'upperLimit': '-0.88'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '-0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.249', 'groupDescription': 'Mixed model repeated measures (MMRM) model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.254', 'groupDescription': 'MMRM model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The modified intent to treat (mITT) population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. 'Overall number of participants analyzed' indicates the number of participants data available for the analysis of this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.'}, {'id': 'OG001', 'title': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'OG002', 'title': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000'}, {'value': '27.4', 'groupId': 'OG001'}, {'value': '17.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.6', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '20.76', 'groupDescription': 'Percentage of responders were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% confidence interval (CI) are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.883', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-10.95', 'ciUpperLimit': '9.40', 'groupDescription': 'Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-30) then participant was considered a Responder and if missing % change from Baseline or \\>(-30) participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥30% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Missing observations at Week 6 are imputed as nonresponses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.'}, {'id': 'OG001', 'title': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'OG002', 'title': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '15.1', 'groupId': 'OG001'}, {'value': '9.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.289', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.8', 'ciLowerLimit': '-4.11', 'ciUpperLimit': '13.73', 'groupDescription': 'Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.837', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-8.85', 'ciUpperLimit': '7.16', 'groupDescription': 'Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-50) then participant is considered a Responder and if missing % change from Baseline or \\>(-50) then participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥50% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Missing observations at Week 6 are imputed as nonresponses.'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN", 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.'}, {'id': 'OG001', 'title': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'OG002', 'title': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}], 'classes': [{'title': 'Pain at its Worst', 'categories': [{'measurements': [{'value': '-0.69', 'groupId': 'OG000', 'lowerLimit': '-1.11', 'upperLimit': '-0.26'}, {'value': '-1.42', 'groupId': 'OG001', 'lowerLimit': '-1.87', 'upperLimit': '-0.97'}, {'value': '-1.38', 'groupId': 'OG002', 'lowerLimit': '-1.81', 'upperLimit': '-0.96'}]}]}, {'title': 'Pain at its Least', 'categories': [{'measurements': [{'value': '-0.69', 'groupId': 'OG000', 'lowerLimit': '-1.13', 'upperLimit': '-0.26'}, {'value': '-1.43', 'groupId': 'OG001', 'lowerLimit': '-1.89', 'upperLimit': '-0.98'}, {'value': '-1.38', 'groupId': 'OG002', 'lowerLimit': '-1.81', 'upperLimit': '-0.95'}]}]}, {'title': 'Pain Right Now', 'categories': [{'measurements': [{'value': '-0.55', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '-0.10'}, {'value': '-1.42', 'groupId': 'OG001', 'lowerLimit': '-1.89', 'upperLimit': '-0.95'}, {'value': '-1.03', 'groupId': 'OG002', 'lowerLimit': '-1.47', 'upperLimit': '-0.59'}]}]}, {'title': 'Interference Score Averaged Over Questions 9A - G', 'categories': [{'measurements': [{'value': '-0.74', 'groupId': 'OG000', 'lowerLimit': '-1.17', 'upperLimit': '-0.30'}, {'value': '-1.00', 'groupId': 'OG001', 'lowerLimit': '-1.46', 'upperLimit': '-0.53'}, {'value': '-0.97', 'groupId': 'OG002', 'lowerLimit': '-1.41', 'upperLimit': '-0.53'}]}]}, {'title': 'General Activity', 'categories': [{'measurements': [{'value': '-0.77', 'groupId': 'OG000', 'lowerLimit': '-1.25', 'upperLimit': '-0.28'}, {'value': '-0.96', 'groupId': 'OG001', 'lowerLimit': '-1.48', 'upperLimit': '-0.44'}, {'value': '-0.82', 'groupId': 'OG002', 'lowerLimit': '-1.31', 'upperLimit': '-0.33'}]}]}, {'title': 'Mood', 'categories': [{'measurements': [{'value': '-0.71', 'groupId': 'OG000', 'lowerLimit': '-1.22', 'upperLimit': '-0.19'}, {'value': '-0.72', 'groupId': 'OG001', 'lowerLimit': '-1.27', 'upperLimit': '-0.16'}, {'value': '-0.65', 'groupId': 'OG002', 'lowerLimit': '-1.18', 'upperLimit': '-0.13'}]}]}, {'title': 'Walking Ability', 'categories': [{'measurements': [{'value': '-0.74', 'groupId': 'OG000', 'lowerLimit': '-1.24', 'upperLimit': '-0.24'}, {'value': '-1.36', 'groupId': 'OG001', 'lowerLimit': '-1.89', 'upperLimit': '-0.83'}, {'value': '-1.22', 'groupId': 'OG002', 'lowerLimit': '-1.73', 'upperLimit': '-0.72'}]}]}, {'title': 'Normal Work', 'categories': [{'measurements': [{'value': '-1.01', 'groupId': 'OG000', 'lowerLimit': '-1.50', 'upperLimit': '-0.53'}, {'value': '-1.07', 'groupId': 'OG001', 'lowerLimit': '-1.58', 'upperLimit': '-0.55'}, {'value': '-1.05', 'groupId': 'OG002', 'lowerLimit': '-1.54', 'upperLimit': '-0.56'}]}]}, {'title': 'Relations with Other People', 'categories': [{'measurements': [{'value': '-0.29', 'groupId': 'OG000', 'lowerLimit': '-0.79', 'upperLimit': '0.20'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '-0.39', 'upperLimit': '0.67'}, {'value': '-0.09', 'groupId': 'OG002', 'lowerLimit': '-0.59', 'upperLimit': '0.41'}]}]}, {'title': 'Sleep', 'categories': [{'measurements': [{'value': '-0.48', 'groupId': 'OG000', 'lowerLimit': '-0.96', 'upperLimit': '-0.01'}, {'value': '-1.45', 'groupId': 'OG001', 'lowerLimit': '-1.96', 'upperLimit': '-0.94'}, {'value': '-1.52', 'groupId': 'OG002', 'lowerLimit': '-2.00', 'upperLimit': '-1.04'}]}]}, {'title': 'Enjoyment of Life', 'categories': [{'measurements': [{'value': '-1.03', 'groupId': 'OG000', 'lowerLimit': '-1.53', 'upperLimit': '-0.52'}, {'value': '-1.05', 'groupId': 'OG001', 'lowerLimit': '-1.59', 'upperLimit': '-0.50'}, {'value': '-1.13', 'groupId': 'OG002', 'lowerLimit': '-1.64', 'upperLimit': '-0.61'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '-0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.298', 'groupDescription': 'Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.290', 'groupDescription': 'Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.74', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '-0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.302', 'groupDescription': 'Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.294', 'groupDescription': 'Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '-0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.309', 'groupDescription': 'Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.111', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.301', 'groupDescription': 'Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.310', 'groupDescription': 'Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.441', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.302', 'groupDescription': 'Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.575', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.346', 'groupDescription': 'General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.880', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.337', 'groupDescription': 'General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.978', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.368', 'groupDescription': 'Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.877', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.358', 'groupDescription': 'Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.354', 'groupDescription': 'Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.163', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.345', 'groupDescription': 'Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.875', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.344', 'groupDescription': 'Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.914', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.335', 'groupDescription': 'Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.219', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '1.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.351', 'groupDescription': 'Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.551', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.341', 'groupDescription': 'Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '-0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.339', 'groupDescription': 'Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.68', 'ciUpperLimit': '-0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.329', 'groupDescription': 'Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.955', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.361', 'groupDescription': 'Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.777', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.351', 'groupDescription': 'Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.', 'statisticalMethod': 'MMRM model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'BPI-DPN: questionnaire that assesses severity of pain \\& its impact on functioning in participants with DPN. It consists of 4 questions that measure pain at its "worst,"least","average","now"(current pain) on 11-point numerical scale 0=no pain;10=worst pain.Score range:0-10 for each of these pain questions, higher scores=greater pain severity. Other 7 questions of BPI evaluate level of interference of pain on daily functioning (general activity,walking,work ability,mood,enjoyment of life,relations,sleep) on 11-point numerical scale, 0=does not interfere;10=completely interferes.Score range:0-10 for each of these intensity questions, higher scores=greater interference. Pain severity \\& pain interference factors are reported as separate categories. Average interference score= mean of 7 interference categories collected in Questions 9A-G, only if 50% (ie at least 4 of 7) of scores were non-missing. Negative change from baseline=improvement. Score range for average interference score: 0-70.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure analysis. Number analyzed indicates the number of participants evaluable for the outcome measure for the specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Discontinuing Treatment Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.'}, {'id': 'OG001', 'title': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'OG002', 'title': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'Lack of efficacy was defined as an increase of 30% from baseline in ADPS based on question 5 of the BPI-DPN. Baseline was defined as the average of the Week 2 Run-in period data collected by participants in the daily pain diary of BPI-DPN. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where 0 = No Pain to 10 = pain as bad as you can imagine, higher score indicates higher pain intensity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) Scale Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.'}, {'id': 'OG001', 'title': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'OG002', 'title': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.28', 'groupId': 'OG000', 'lowerLimit': '3.04', 'upperLimit': '3.52'}, {'value': '2.93', 'groupId': 'OG001', 'lowerLimit': '2.69', 'upperLimit': '3.17'}, {'value': '3.13', 'groupId': 'OG002', 'lowerLimit': '2.88', 'upperLimit': '3.38'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.163', 'groupDescription': 'Analysis of variance (ANOVA) model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.351', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.165', 'groupDescription': 'ANOVA model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': "PGIC is a 7-point rating scale that assesses participant's belief about the overall improvement experienced after the end of treatment, where 1= very much improved to 7 = very much worse. Higher score indicates worsening.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Overall number of participants analyzed indicates the number of participants evaluable for the analysis of the outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving a ≥30% Reduction in Pain Intensity at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.'}, {'id': 'OG001', 'title': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'OG002', 'title': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'As none of the participants discontinued due to loss of efficacy during Weeks 6 to 11, median and full range could not be estimated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'As none of the participants discontinued due to loss of efficacy during Weeks 6 to 11, median and full range could not be estimated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'As none of the participants discontinued due to loss of efficacy during Weeks 6 to 11, median and full range could not be estimated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 6 to 11', 'description': 'For participants who achieved ≥30% reduction in ADPS based on Question 5 of the BPI-DPN at Week 6, the time to loss of efficacy was defined as the time from the date of Week 6 visit to the date of termination of safety follow-up due to lack of efficacy. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Participants who had ≥30% Reduction in Pain Intensity in ADPS at Week 6 were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Double-blind Treatment Period)', 'description': 'Following a 2-week single-blind Run-in period, participants were randomized to receive a single loading dose of LX9211 matching placebo tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.'}, {'id': 'OG001', 'title': 'LX9211 100 mg/10 mg (Double-blind Treatment Period)', 'description': 'Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 100 mg tablet, orally, on Day 1 and maintenance doses of 10 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.'}, {'id': 'OG002', 'title': 'LX9211 200 mg/20 mg (Double-blind Treatment Period)', 'description': 'Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.'}, {'id': 'OG003', 'title': 'Placebo (Single-blind Follow-up Period)', 'description': 'Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.'}, {'id': 'OG004', 'title': 'LX9211 100 mg/10 mg (Single-blind Follow-up Period)', 'description': 'Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.'}, {'id': 'OG005', 'title': 'LX9211 200 mg/20 mg Single-blind Follow-up Period)', 'description': 'Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study drug after randomization up to the end of study (up to Week 11)', 'description': 'Adverse Events (AE) is defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs that occur or worsen after the first dose of study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. AEs were collected and reported for treatment period and safety follow up period separately.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, once daily (QD) from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.'}, {'id': 'FG001', 'title': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'FG002', 'title': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}], 'periods': [{'title': 'Double-Blind Period (Up to Week 6)', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized Participants.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'Subject Choice Unrelated to Adverse Event/Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Follow up Period (Weeks 7 to 11)', 'milestones': [{'type': 'STARTED', 'comment': 'Some of the participants who discontinued in double blind treatment period were also included in safety follow-up.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '92'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at multiple investigative sites in the United States from 03 Sep 2020 to 28 Jun 2022.', 'preAssignmentDetails': 'Participants with diagnosis of diabetic peripheral neuropathic pain were randomized in a 1:1:1 ratio to Placebo, LX9211 100 milligrams (mg)/10 mg and LX9211 200 mg/20 mg arm groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.'}, {'id': 'BG001', 'title': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'BG002', 'title': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '62.0', 'spread': '9.59', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '9.26', 'groupId': 'BG001'}, {'value': '61.8', 'spread': '10.96', 'groupId': 'BG002'}, {'value': '62.2', 'spread': '9.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '244', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Average Daily Pain Score (ADPS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '316', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.54', 'spread': '1.154', 'groupId': 'BG000'}, {'value': '6.59', 'spread': '1.091', 'groupId': 'BG001'}, {'value': '6.53', 'spread': '1.028', 'groupId': 'BG002'}, {'value': '6.55', 'spread': '1.089', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Average Daily Pain Score (ADPS) is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average" on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. "Number analyzed" indicates number of participants with data available for analysis at Baseline.'}], 'populationDescription': 'The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-09', 'size': 27186893, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-22T10:03', 'hasProtocol': True}, {'date': '2022-06-07', 'size': 5722076, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-22T05:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'dispFirstSubmitDate': '2023-05-22', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2020-06-29', 'resultsFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2020-06-29', 'dispFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-20', 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-30) then participant was considered a Responder and if missing % change from Baseline or \\>(-30) participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥30% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.'}, {'measure': 'Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-50) then participant is considered a Responder and if missing % change from Baseline or \\>(-50) then participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥50% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.'}, {'measure': "Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN", 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'BPI-DPN: questionnaire that assesses severity of pain \\& its impact on functioning in participants with DPN. It consists of 4 questions that measure pain at its "worst,"least","average","now"(current pain) on 11-point numerical scale 0=no pain;10=worst pain.Score range:0-10 for each of these pain questions, higher scores=greater pain severity. Other 7 questions of BPI evaluate level of interference of pain on daily functioning (general activity,walking,work ability,mood,enjoyment of life,relations,sleep) on 11-point numerical scale, 0=does not interfere;10=completely interferes.Score range:0-10 for each of these intensity questions, higher scores=greater interference. Pain severity \\& pain interference factors are reported as separate categories. Average interference score= mean of 7 interference categories collected in Questions 9A-G, only if 50% (ie at least 4 of 7) of scores were non-missing. Negative change from baseline=improvement. Score range for average interference score: 0-70.'}, {'measure': 'Percentage of Participants Discontinuing Treatment Due to Lack of Efficacy', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': 'Lack of efficacy was defined as an increase of 30% from baseline in ADPS based on question 5 of the BPI-DPN. Baseline was defined as the average of the Week 2 Run-in period data collected by participants in the daily pain diary of BPI-DPN. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where 0 = No Pain to 10 = pain as bad as you can imagine, higher score indicates higher pain intensity.'}, {'measure': 'Patient Global Impression of Change (PGIC) Scale Score at Week 6', 'timeFrame': 'Baseline (Week 2 of the Run-in period) to Week 6', 'description': "PGIC is a 7-point rating scale that assesses participant's belief about the overall improvement experienced after the end of treatment, where 1= very much improved to 7 = very much worse. Higher score indicates worsening."}, {'measure': 'Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving a ≥30% Reduction in Pain Intensity at Week 6', 'timeFrame': 'Weeks 6 to 11', 'description': 'For participants who achieved ≥30% reduction in ADPS based on Question 5 of the BPI-DPN at Week 6, the time to loss of efficacy was defined as the time from the date of Week 6 visit to the date of termination of safety follow-up due to lack of efficacy. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'First dose of study drug after randomization up to the end of study (up to Week 11)', 'description': 'Adverse Events (AE) is defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs that occur or worsen after the first dose of study medication.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Peripheral Neuropathy', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '35257579', 'type': 'DERIVED', 'citation': "Luo G, Chen L, Kostich WA, Hamman B, Allen J, Easton A, Bourin C, Gulianello M, Lippy J, Nara S, Maishal TK, Thiyagarajan K, Jalagam P, Pattipati SN, Dandapani K, Dokania M, Vattikundala P, Sharma V, Elavazhagan S, Verma MK, Das ML, Wagh S, Balakrishnan A, Johnson BM, Santone KS, Thalody G, Denton R, Saminathan H, Holenarsipur VK, Kumar A, Rao A, Putlur SP, Sarvasiddhi SK, Shankar G, Louis JV, Ramarao M, Conway CM, Li YW, Pieschl R, Tian Y, Hong Y, Ditta J, Mathur A, Li J, Smith D, Pawluczyk J, Sun D, Yip S, Wu DR, Vetrichelvan M, Gupta A, Wilson A, Gopinathan S, Wason S, Bristow L, Albright CF, Bronson JJ, Macor JE, Dzierba CD. Discovery of (S)-1-((2',6-Bis(difluoromethyl)-[2,4'-bipyridin]-5-yl)oxy)-2,4-dimethylpentan-2-amine (BMS-986176/LX-9211): A Highly Selective, CNS Penetrable, and Orally Active Adaptor Protein-2 Associated Kinase 1 Inhibitor in Clinical Trials for the Treatment of Neuropathic Pain. J Med Chem. 2022 Mar 24;65(6):4457-4480. doi: 10.1021/acs.jmedchem.1c02131. Epub 2022 Mar 8."}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has given written informed consent to participate in the study in accordance with local regulations\n* Adult male and female participants ≥18 years of age at the time of screening\n* Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening\n* Diagnosis of diabetic peripheral neuropathic pain (DPNP) at Screening\n* Pain from DPN present for at least 6 months\n* Haemoglobin A1C ≤11% at screening\n* Stable regimen for the treatment of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) for ≥1 month prior to Screening\n\nExclusion Criteria:\n\n* Presence of other painful conditions that may confound assessment or self-evaluation of DPNP\n* History of major depressive episode, active, significant psychiatric disorders\n* History of clinically significant drug or alcohol use disorder\n* History of neurolytic or neurosurgical therapy for DPNP\n* Use of opioid medications for management of DPNP within the 2 months prior to Screening Visit\n* Use of non-steroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to the Screening Visit'}, 'identificationModule': {'nctId': 'NCT04455633', 'acronym': 'RELIEF-DPN 1', 'briefTitle': 'Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lexicon Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain', 'orgStudyIdInfo': {'id': 'LX9211.1-201-DPN'}, 'secondaryIdInfos': [{'id': 'LX9211.201', 'type': 'OTHER', 'domain': 'Lexicon Pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, once daily (QD) from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.', 'interventionNames': ['Drug: LX9211 Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LX9211 100 mg/10 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 milligrams (mg), tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.', 'interventionNames': ['Drug: LX9211']}, {'type': 'EXPERIMENTAL', 'label': 'LX9211 200 mg/20 mg', 'description': 'Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.', 'interventionNames': ['Drug: LX9211']}], 'interventions': [{'name': 'LX9211', 'type': 'DRUG', 'description': 'Oral Tablets', 'armGroupLabels': ['LX9211 100 mg/10 mg', 'LX9211 200 mg/20 mg']}, {'name': 'LX9211 Matching Placebo', 'type': 'DRUG', 'description': 'Oral Tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85286', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Lexicon Investigational Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 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