Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT05088460
Status:
TERMINATED
Last Update Posted:
2025-10-16
First Post:
2021-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
Sponsor:
Organization:
Raw JSON
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The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From signing of informed consent up to day 281 (end of study)', 'eventGroups': [{'id': 'EG000', 'title': 'DBTP Arm 1 Cohort A: Placebo', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'DBTP Arm 2 Cohort A: REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 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Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}, {'id': 'OG003', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'categories': [{'measurements': [{'value': '36.78', 'spread': '44.863', 'groupId': 'OG000'}, {'value': '-35.59', 'spread': '8.754', 'groupId': 'OG001'}, {'value': '10.07', 'spread': '49.689', 'groupId': 'OG002'}, {'value': '-37.62', 'spread': '13.752', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 12', 'description': 'Percent change in fasting serum TG was reported for participants with elevated baseline fasting TG (\\>200 mg/dL) in Cohort B and Cohorts A + B.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. 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Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.30', 'spread': '46.306', 'groupId': 'OG000'}, {'value': '36.78', 'spread': '44.863', 'groupId': 'OG001'}, {'value': '10.07', 'spread': '49.689', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-29.79', 'spread': '35.109', 'groupId': 'OG000'}, {'value': '-8.96', 'spread': '13.673', 'groupId': 'OG001'}, {'value': '-23.84', 'spread': '30.923', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Percent change in fasting serum TG was reported for participants in Study Arm 1.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-38.97', 'spread': '16.998', 'groupId': 'OG000'}, {'value': '-35.59', 'spread': '8.754', 'groupId': 'OG001'}, {'value': '-37.62', 'spread': '13.752', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-30.77', 'spread': '48.883', 'groupId': 'OG000'}, {'value': '-5.30', 'spread': '51.158', 'groupId': 'OG001'}, {'value': '-18.04', 'spread': '48.282', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Percent change in fasting serum TG was reported for participants in Study Arm 2.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.406', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.427', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.406', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.694', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.802', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.826', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Change from baseline in HbA1c was reported for participants in Study Arm 1.', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.92', 'spread': '1.068', 'groupId': 'OG000'}, {'value': '-0.78', 'spread': '0.826', 'groupId': 'OG001'}, {'value': '-0.86', 'spread': '0.931', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.98', 'spread': '1.357', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '1.068', 'groupId': 'OG001'}, {'value': '-0.77', 'spread': '1.188', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Change from baseline in HbA1c was reported for participants in Study Arm 2.', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '29.55', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '60.37', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '42.54', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '29.65', 'groupId': 'OG000'}, {'value': '-15.5', 'spread': '6.36', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '26.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Change from baseline in fasting glucose was reported for participants in Study Arm 1.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '36.55', 'groupId': 'OG000'}, {'value': '-19.5', 'spread': '22.87', 'groupId': 'OG001'}, {'value': '-10.9', 'spread': '31.17', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '26.35', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '58.59', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '42.71', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Change from baseline in fasting glucose was reported for participants in Study Arm 2.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Weeks 12 and 24 in Liver Fat Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) (Study Arm 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.44', 'spread': '18.576', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '9.919', 'groupId': 'OG001'}, {'value': '-7.16', 'spread': '15.214', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-47.21', 'spread': '22.176', 'groupId': 'OG000'}, {'value': '44.81', 'spread': 'NA', 'comment': 'SD not calculable with n=1', 'groupId': 'OG001'}, {'value': '-16.54', 'spread': '55.394', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Percent change from baseline in MRI-PDFF was reported for participants with baseline MRI-PDFF ≥8.5% in Study Arm 1.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with baseline MRI-PDFF ≥8.5%, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Weeks 12 and 24 in Liver Fat MRI-PDFF (Study Arm 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-17.05', 'spread': '25.788', 'groupId': 'OG000'}, {'value': '-18.80', 'spread': '17.300', 'groupId': 'OG001'}, {'value': '-17.92', 'spread': '20.351', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-24.33', 'spread': '27.151', 'groupId': 'OG000'}, {'value': '-19.53', 'spread': '19.324', 'groupId': 'OG001'}, {'value': '-22.27', 'spread': '22.353', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Percent change from baseline in MRI-PDFF was reported for participants with baseline liver fat MRI-PDFF ≥8.5% in Study Arm 2.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with baseline MRI-PDFF ≥8.5%, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Highest Hunger Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG003', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG004', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}, {'id': 'OG005', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.060', 'spread': '0.9009', 'groupId': 'OG000'}, {'value': '-0.538', 'spread': '0.4679', 'groupId': 'OG001'}, {'value': '-0.240', 'spread': '0.2483', 'groupId': 'OG002'}, {'value': '-0.415', 'spread': '0.7539', 'groupId': 'OG003'}, {'value': '-0.132', 'spread': '0.6929', 'groupId': 'OG004'}, {'value': '-0.489', 'spread': '0.5614', 'groupId': 'OG005'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.330', 'spread': '0.3684', 'groupId': 'OG000'}, {'value': '-0.018', 'spread': '0.6228', 'groupId': 'OG001'}, {'value': '-0.383', 'spread': '0.1550', 'groupId': 'OG002'}, {'value': '-0.285', 'spread': '0.6180', 'groupId': 'OG003'}, {'value': '-0.350', 'spread': '0.2919', 'groupId': 'OG004'}, {'value': '-0.137', 'spread': '0.5975', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The highest hunger score asked participants to rate their highest hunger that day on a scale from 0 to 4, with higher scores representing the higher perceived hunger. A negative change from baseline indicated a reduction in perceived hunger.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Lowest Hunger Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG003', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG004', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}, {'id': 'OG005', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.185', 'spread': '0.8013', 'groupId': 'OG000'}, {'value': '-0.475', 'spread': '0.4630', 'groupId': 'OG001'}, {'value': '-0.338', 'spread': '0.4287', 'groupId': 'OG002'}, {'value': '-0.173', 'spread': '0.3625', 'groupId': 'OG003'}, {'value': '-0.024', 'spread': '0.7006', 'groupId': 'OG004'}, {'value': '-0.354', 'spread': '0.4328', 'groupId': 'OG005'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.128', 'spread': '0.0622', 'groupId': 'OG000'}, {'value': '0.046', 'spread': '0.6776', 'groupId': 'OG001'}, {'value': '-0.103', 'spread': '0.2230', 'groupId': 'OG002'}, {'value': '0.308', 'spread': '0.9603', 'groupId': 'OG003'}, {'value': '-0.119', 'spread': '0.1288', 'groupId': 'OG004'}, {'value': '0.162', 'spread': '0.7710', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The lowest hunger score asked participants to rate their lowest hunger that day on a scale from 0 to 4, with higher scores indicating higher perceived hunger. A negative change from baseline score indicated a reduction in perceived lowest hunger.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Felt Hungry Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG003', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG004', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}, {'id': 'OG005', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.248', 'spread': '0.8642', 'groupId': 'OG000'}, {'value': '-0.550', 'spread': '0.5334', 'groupId': 'OG001'}, {'value': '-0.168', 'spread': '0.2900', 'groupId': 'OG002'}, {'value': '0.008', 'spread': '0.9139', 'groupId': 'OG003'}, {'value': '0.082', 'spread': '0.6993', 'groupId': 'OG004'}, {'value': '-0.327', 'spread': '0.7206', 'groupId': 'OG005'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.3932', 'groupId': 'OG000'}, {'value': '0.120', 'spread': '0.4374', 'groupId': 'OG001'}, {'value': '-0.183', 'spread': '0.0603', 'groupId': 'OG002'}, {'value': '-0.138', 'spread': '0.6595', 'groupId': 'OG003'}, {'value': '-0.059', 'spread': '0.3163', 'groupId': 'OG004'}, {'value': '0.006', 'spread': '0.5265', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among participants with lipodystrophy. The felt hungry score asked how much time participants felt hunger that day on a scale from 0 to 4, with higher scores indicating more time feeling hungry. A negative change from baseline score indicated a reduction in time spent feeling hungry.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Fullness Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG001', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG002', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG003', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG004', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}, {'id': 'OG005', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.063', 'spread': '1.1988', 'groupId': 'OG000'}, {'value': '-0.267', 'spread': '0.5381', 'groupId': 'OG001'}, {'value': '-1.180', 'spread': '0.3764', 'groupId': 'OG002'}, {'value': '-0.535', 'spread': '0.5736', 'groupId': 'OG003'}, {'value': '-0.434', 'spread': '1.1216', 'groupId': 'OG004'}, {'value': '-0.374', 'spread': '0.5383', 'groupId': 'OG005'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.182', 'spread': '0.6474', 'groupId': 'OG000'}, {'value': '0.012', 'spread': '0.6474', 'groupId': 'OG001'}, {'value': '-1.193', 'spread': '0.6630', 'groupId': 'OG002'}, {'value': '-0.178', 'spread': '0.8032', 'groupId': 'OG003'}, {'value': '-0.561', 'spread': '0.7994', 'groupId': 'OG004'}, {'value': '-0.072', 'spread': '0.6793', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The fullness score asked participants to rate how often they felt full after eating that day on a scale from 0 to 4, with higher scores indicating higher feeling of fullness. A negative change from baseline indicated a reduced feeling of fullness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '8', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'DBTP Arm 1 Cohort A: Placebo', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.'}, {'id': 'OG001', 'title': 'DBTP Arm 2 Cohort A: REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.'}, {'id': 'OG002', 'title': 'DBTP Arm 1 Cohort B: Placebo', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.'}, {'id': 'OG003', 'title': 'DBTP Arm 2 Cohort B: REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.'}, {'id': 'OG004', 'title': 'DBTP Arm 1 Combined Cohort A + B: Placebo', 'description': 'DBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}, {'id': 'OG005', 'title': 'DBTP Arm 2 Combined Cohort A + B: REGN4461', 'description': 'DBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}, {'id': 'OG006', 'title': 'SBTP Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG007', 'title': 'SBTP Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG008', 'title': 'SBTP Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'OG009', 'title': 'SBTP Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'OG010', 'title': 'SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': 'SBTP "Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}, {'id': 'OG011', 'title': 'SBTP Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': 'SBTP "Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 169', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DB SAF included all participants who received any double-blind study drug in DBTP. The single-blind safety analysis set (SB SAF) included all randomized participants who received any single-blind study drug in the single-blind treatment period (SBTP).'}, {'type': 'SECONDARY', 'title': 'Concentrations of REGN4461 in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}, {'id': 'OG001', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'title': 'Week 0 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 0 (post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '232', 'spread': '83.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '64.3', 'spread': '24.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '52.5', 'spread': '13.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '60.2', 'spread': '19.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '58.8', 'spread': '23.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '62.0', 'spread': '36.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '68.8', 'spread': '38.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '79.6', 'spread': '49.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '87.1', 'spread': '57.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '252', 'spread': '50.7', 'groupId': 'OG000'}, {'value': '87.6', 'spread': '49.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.4', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '97.6', 'spread': '68.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.6', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '92.8', 'spread': '68.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 15 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.2', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '90.5', 'spread': '59.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.8', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '103', 'spread': '76.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 17 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.4', 'spread': '30.8', 'groupId': 'OG000'}, {'value': '92.1', 'spread': '73.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 18 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.1', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '95.0', 'spread': '79.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 21 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.3', 'spread': '40.0', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '51.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 28 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '23.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0663', 'spread': '0.0705', 'groupId': 'OG000'}, {'value': '0.189', 'spread': '0.281', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0110', 'spread': '0.0330', 'groupId': 'OG000'}, {'value': '0.0373', 'spread': '0.0788', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 1, 2, 3, 4, 5, 6, 9, 12, 13, 14, 15, 16, 17, 18, 21, 28, 32 and 36. Weeks 0 and 12 collected pre- and post-dose. All other time points were only pre-dose.', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set was defined as all randomized participants who received any study drug and have at least 1 non-missing measurement of REGN4461 concentration following the first dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 Combined Cohort A + B: Placebo to REGN4461', 'description': '"Arm 1 Cohort A" and "Arm 1 Cohort B" combined'}, {'id': 'OG001', 'title': 'Arm 2 Combined Cohort A + B: REGN4461 to REGN4461', 'description': '"Arm 2 Cohort A" and "Arm 2 Cohort B" combined'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 281', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADA analysis set included all treated participants who received any amount of study drug and had at least one non-missing anti-drug antibody result following the first dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'FG001', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'FG002', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'FG003', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Completed Treatment During DBTP', 'comment': 'Double-blind Treatment Period (DBTP)', 'achievements': [{'comment': '1 participant prematurely discontinued before completing the DBTP at the request of the sponsor due to the early study termination.', 'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Completed Treatment During SBTP', 'comment': 'Single-blind Treatment Period (SBTP)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'comment': '1 participant prematurely discontinued study treatment before completing SBTP at the request of the sponsor due to the early study termination.', 'groupId': 'FG001', 'numSubjects': '5'}, {'comment': '1 participant completed the DBTP but was prematurely discontinued before entering the SBTP at the request of the sponsor due to the early study termination.', 'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'comment': 'Completed study All 20 participants were considered to have completed the study, including the 3 participants who were discontinued at the request of the sponsor during treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 66 participants were screened, of whom 20 were randomized and received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1 Cohort A: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'BG001', 'title': 'Arm 2 Cohort A: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'BG002', 'title': 'Arm 1 Cohort B: Placebo to REGN4461', 'description': 'Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.'}, {'id': 'BG003', 'title': 'Arm 2 Cohort B: REGN4461 to REGN4461', 'description': 'Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'spread': '16.79', 'groupId': 'BG000'}, {'value': '43.8', 'spread': '13.47', 'groupId': 'BG001'}, {'value': '48.0', 'spread': '11.97', 'groupId': 'BG002'}, {'value': '40.3', 'spread': '12.82', 'groupId': 'BG003'}, {'value': '43.0', 'spread': '13.40', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fasting Triglycerides Serum Concentration', 'classes': [{'categories': [{'measurements': [{'value': '1100.9', 'groupId': 'BG000', 'lowerLimit': '405', 'upperLimit': '5681'}, {'value': '737.8', 'groupId': 'BG001', 'lowerLimit': '308', 'upperLimit': '2487'}, {'value': '675.0', 'groupId': 'BG002', 'lowerLimit': '426', 'upperLimit': '1534'}, {'value': '336.2', 'groupId': 'BG003', 'lowerLimit': '150', 'upperLimit': '1376'}, {'value': '698.3', 'groupId': 'BG004', 'lowerLimit': '150', 'upperLimit': '5681'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '1.62', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '1.76', 'groupId': 'BG001'}, {'value': '6.9', 'spread': '0.91', 'groupId': 'BG002'}, {'value': '8.6', 'spread': '2.06', 'groupId': 'BG003'}, {'value': '8.2', 'spread': '1.68', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The double-blind safety analysis set (DB SAF) included all randomized participants who received any study drug during the double-blind treatment period (DBTP).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-03', 'size': 1066511, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-16T10:44', 'hasProtocol': True}, {'date': '2024-05-20', 'size': 1052389, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-16T10:45', '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': 20}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'dispFirstSubmitDate': '2024-11-04', 'completionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2021-10-12', 'resultsFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2021-10-12', 'dispFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-06-30', 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A)', 'timeFrame': 'Baseline to week 12', 'description': 'Percentage change in fasting serum TG was reported for participants with elevated baseline fasting TG (\\> 200 mg/dL) and with baseline leptin \\< 8.0 ng/mL (Cohort A).'}, {'measure': 'Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A)', 'timeFrame': 'Baseline to week 12', 'description': 'Change in HbA1c was reported for participants with elevated baseline HbA1c (\\> 7.0%) and with baseline leptin \\< 8.0 ng/mL (Cohort A).'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B)', 'timeFrame': 'Baseline to week 12', 'description': 'Percent change in fasting serum TG was reported for participants with elevated baseline fasting TG (\\>200 mg/dL) in Cohort B and Cohorts A + B.'}, {'measure': 'Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B)', 'timeFrame': 'Baseline to week 12', 'description': 'Change in HbA1c was reported for participants with elevated baseline HbA1c (\\>7.0%) in Cohort B and Cohorts A + B.'}, {'measure': 'Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Percent change in fasting serum TG was reported for participants in Study Arm 1.'}, {'measure': 'Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Percent change in fasting serum TG was reported for participants in Study Arm 2.'}, {'measure': 'Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Change from baseline in HbA1c was reported for participants in Study Arm 1.'}, {'measure': 'Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Change from baseline in HbA1c was reported for participants in Study Arm 2.'}, {'measure': 'Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Change from baseline in fasting glucose was reported for participants in Study Arm 1.'}, {'measure': 'Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Change from baseline in fasting glucose was reported for participants in Study Arm 2.'}, {'measure': 'Percent Change From Baseline to Weeks 12 and 24 in Liver Fat Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) (Study Arm 1)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Percent change from baseline in MRI-PDFF was reported for participants with baseline MRI-PDFF ≥8.5% in Study Arm 1.'}, {'measure': 'Percent Change From Baseline to Weeks 12 and 24 in Liver Fat MRI-PDFF (Study Arm 2)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Percent change from baseline in MRI-PDFF was reported for participants with baseline liver fat MRI-PDFF ≥8.5% in Study Arm 2.'}, {'measure': 'Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Highest Hunger Score', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The highest hunger score asked participants to rate their highest hunger that day on a scale from 0 to 4, with higher scores representing the higher perceived hunger. A negative change from baseline indicated a reduction in perceived hunger.'}, {'measure': 'Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Lowest Hunger Score', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The lowest hunger score asked participants to rate their lowest hunger that day on a scale from 0 to 4, with higher scores indicating higher perceived hunger. A negative change from baseline score indicated a reduction in perceived lowest hunger.'}, {'measure': 'Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Felt Hungry Score', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among participants with lipodystrophy. The felt hungry score asked how much time participants felt hunger that day on a scale from 0 to 4, with higher scores indicating more time feeling hungry. A negative change from baseline score indicated a reduction in time spent feeling hungry.'}, {'measure': 'Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Fullness Score', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The fullness score asked participants to rate how often they felt full after eating that day on a scale from 0 to 4, with higher scores indicating higher feeling of fullness. A negative change from baseline indicated a reduced feeling of fullness.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 169'}, {'measure': 'Concentrations of REGN4461 in Serum', 'timeFrame': 'Weeks 0, 1, 2, 3, 4, 5, 6, 9, 12, 13, 14, 15, 16, 17, 18, 21, 28, 32 and 36. Weeks 0 and 12 collected pre- and post-dose. All other time points were only pre-dose.'}, {'measure': 'Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response', 'timeFrame': 'Up to Day 281'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Familial Partial Lipodystrophy', 'Metabolic Abnormalities']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/', 'label': 'A Plain Language Summary is available on TrialSummaries.com'}]}, 'descriptionModule': {'briefSummary': 'Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin \\<8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL\n\nThe primary objectives will be evaluated for patients in Cohort A only:\n\n* To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG\n* To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c)\n\nThe following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B:\n\n* To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia\n* To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia\n\nThe following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B:\n\n* To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis\n* To evaluate the effect of REGN4461 on hunger\n* To evaluate safety and tolerability of REGN4461\n* To characterize the concentration profile of REGN4461 over time\n* To assess immunogenicity to REGN4461'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Clinical diagnosis of familial partial lipodystrophy as defined in the protocol\n* Fasting leptin level ≤20.0 ng/ml, as determined during the screening period\n* Presence of significant metabolic abnormalities related to glucose and triglycerides (TGs) as defined in the protocol\n* Stable body weight within the 3 months prior to screening (no gain or loss of \\>5% current weight)\n* Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Atkins, Paleo, Vegetarianism, Veganism)\n* No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol\n\nKey Exclusion Criteria:\n\n* Treatment with metreleptin within 3 months of the screening visit\n* Patients with a diagnosis of generalized lipodystrophy\n* Patients with a diagnosis of acquired lipodystrophy\n* Pregnant or breastfeeding women\n\nNOTE: Other protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05088460', 'acronym': 'LEAP', 'briefTitle': 'A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients With Familial Partial Lipodystrophy', 'orgStudyIdInfo': {'id': 'R4461-PLD-20100'}, 'secondaryIdInfos': [{'id': '2021-000138-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Arm 1', 'description': 'Randomized to placebo for 12 weeks and then crossover to REGN4461 for 12 weeks', 'interventionNames': ['Drug: REGN4461', 'Drug: Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Study Arm 2', 'description': 'Randomized to receive REGN4461 for 24 weeks', 'interventionNames': ['Drug: REGN4461']}], 'interventions': [{'name': 'REGN4461', 'type': 'DRUG', 'otherNames': ['mibavademab'], 'description': 'Intravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).', 'armGroupLabels': ['Study Arm 1', 'Study Arm 2']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'description': 'Intravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).', 'armGroupLabels': ['Study Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Excel Medical Clinical Trials - A Flourish Research Site', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institute of Health', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'ICAN, Institute of Cardiometabolism and Nutrition', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '35100', 'city': 'Izmir', 'state': 'Bornova', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Faculty of Medicine', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing', 'accessCriteria': 'Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}