Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-02 @ 9:02 AM
Study NCT ID:
NCT04524403
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606526', 'term': 'CORT118335'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@corcept.com', 'phone': '650-327-3270', 'title': 'Medical Director', 'organization': 'Corcept Therapeutics Incorporated'}, 'certainAgreement': {'otherDetails': 'No individual publications will be allowed before publication of the multicenter results, except as agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the Sponsor for review before submission to the publisher.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Day 1 to Week 30', 'description': 'The Safety Population was patients who received ≥1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Miricorlilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 8, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Miricorlilant 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 3, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.\n\nPlacebo: Placebo for once-daily oral dosing', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 4, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Regressive behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorlilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Miricorlilant 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.\n\nPlacebo: Placebo for oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'spread': '0.644', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.631', 'groupId': 'OG001'}, {'value': '-1.66', 'spread': '0.644', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7870', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '2.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4018', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '2.51', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Day 1 and Week 26', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had body weight measurements at Baseline and on Week 26.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant 600 mg or 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive miricorilant 600 mg (4 X 150 mg) tablets or 900 mg (6 X 150 mg) tablets orally once-daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.16', 'spread': '0.454', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '0.642', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5228', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '2.02', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Day 1 and Week 26', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had body weight measurements at Baseline and on Week 26.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorlilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Miricorlilant 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.\n\nPlacebo: Placebo for oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2537', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.781', 'ciLowerLimit': '0.661', 'ciUpperLimit': '4.802', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8740', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.916', 'ciLowerLimit': '0.308', 'ciUpperLimit': '2.722', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline Day 1 to Week 26', 'description': 'Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had Baseline and ≥1 body weight measurement on or after Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorlilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Miricorlilant 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.\n\nPlacebo: Placebo for oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0077', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.0075', 'groupId': 'OG001'}, {'value': '0.002', 'spread': '0.0077', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9870', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.000', 'ciLowerLimit': '-0.021', 'ciUpperLimit': '0.021', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4624', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.008', 'ciLowerLimit': '-0.013', 'ciUpperLimit': '0.029', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Day 1 and Week 26', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had weight and hip measurements at Baseline and on Week 26.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With One or More Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorlilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Miricorlilant 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.\n\nPlacebo: Placebo for oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline Day 1 to Week 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population was patients who received ≥1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With One or More Treatment-emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorlilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Miricorlilant 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.\n\nPlacebo: Placebo for oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline Day 1 to Week 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population was patients who received ≥1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorlilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Miricorlilant 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo once daily for 26 weeks.\n\nPlacebo: Placebo for oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline Day 1 to Week 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population was patients who received ≥1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Miricorlilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'FG001', 'title': 'Miricorlilant 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.\n\nPlacebo: Placebo for once-daily oral dosing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Non-compliant with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Miricorlilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'BG001', 'title': 'Miricorlilant 900 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.\n\nMiricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.\n\nPlacebo: Placebo for once-daily oral dosing'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '10.80', 'groupId': 'BG000'}, {'value': '46.4', 'spread': '10.88', 'groupId': 'BG001'}, {'value': '47.5', 'spread': '10.27', 'groupId': 'BG002'}, {'value': '46.5', 'spread': '10.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 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{'date': '2020-08-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Patients With One or More Treatment-emergent Adverse Events', 'timeFrame': 'Baseline Day 1 to Week 30'}, {'measure': 'Number of Patients With One or More Treatment-emergent Serious Adverse Events', 'timeFrame': 'Baseline Day 1 to Week 30'}, {'measure': 'Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation', 'timeFrame': 'Baseline Day 1 to Week 30'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline Day 1 and Week 26'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo', 'timeFrame': 'Baseline Day 1 and Week 26'}, {'measure': 'Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo', 'timeFrame': 'Baseline Day 1 to Week 26', 'description': 'Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo'}, {'measure': 'Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo', 'timeFrame': 'Baseline Day 1 and Week 26'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antipsychotic-induced weight gain (AIWG)', 'Obesity', 'Weight Gain', 'Mental disorders', 'Schizophrenia', 'Risperidone', 'Paliperidone', 'Quetiapine', 'Olanzapine'], 'conditions': ['Antipsychotic-induced Weight Gain (AIWG)']}, 'descriptionModule': {'briefSummary': 'This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia who are currently taking olanzapine, risperidone, paliperidone, or quetiapine.\n\nPatients who meet the criteria for the Study CORT118335-877 will be randomized on Day 1 to receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of schizophrenia\n* Are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications\n* Must be on a stable dose of medication for 1 month prior to Screening\n* Have a BMI ≥30 kg/m\\^2.\n\nExclusion Criteria:\n\n* Have a history of a medical condition affecting body weight (eg, poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome)\n* Have poorly controlled diabetes mellitus\n* Have poorly controlled hypertension\n* Have a history of symptomatic hypotension\n* Have a history of orthostatic hypotension\n* Have a history of a seizure disorder.'}, 'identificationModule': {'nctId': 'NCT04524403', 'briefTitle': 'A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corcept Therapeutics'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)', 'orgStudyIdInfo': {'id': 'CORT118335-877'}}, 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