Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-02 @ 11:36 AM
Study NCT ID:
NCT03818256
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], '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'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood 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 Corcept. The Investigator agrees to submit all manuscripts or abstracts to Corcept for review before submission to the publisher.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Day 1 to Week 16', 'description': 'The Safety Population included patients who received ≥1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 12, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 5, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Hyperthermia malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.98', 'spread': '0.414', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '0.415', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8511', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '1.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Day 1 and Week 12', '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 assessed at Baseline and on Week 12.'}, {'type': 'PRIMARY', 'title': 'Number of Patients With One or More Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Follow-up Visit (Week 16)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included patients who received ≥1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Patients With One or More Treatment-emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Follow-up Visit (up to Week 16)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included patients who received ≥1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Follow-up Visit (up to Week 16)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included patients who received ≥1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving More Than or Equal to 5% Weight Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.150', 'ciUpperLimit': '4.474', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline Day 1 to Week 12', '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 taken on or after Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HOMA-IR at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '1.080', 'groupId': 'OG000', 'lowerLimit': '-2.020', 'upperLimit': '3.780'}, {'value': '0.890', 'groupId': 'OG001', 'lowerLimit': '-0.970', 'upperLimit': '2.400'}]}]}], 'analyses': [{'pValue': '0.9285', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Location shift', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.175', 'ciLowerLimit': '-2.860', 'ciUpperLimit': '2.780', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline Day 1 and Week 12', 'description': 'HOMA-IR = \\[fasting plasma glucose (mg/dL) X fasting insulin (µU/mL)\\]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be ≤1.0 to be considered normal. A score \\>1.9 indicates early insulin resistance and a score \\>2.9 indicates significant insulin resistance.', 'unitOfMeasure': 'HOMA-IR score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had HOMA-IR assessed at Baseline and on Week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist-to-hip Ratio at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '0.008', 'spread': '0.0092', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.0091', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5669', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.007', 'ciLowerLimit': '-0.018', 'ciUpperLimit': '0.033', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline Day 1 and Week 12', 'description': 'Waist-to-hip ratio compares the circumference of the waist to the circumference of the hips. The ratio is calculated by dividing the waist measurement by the hip measurement, using the same units of measurement for both. A waist-to-hip ratio \\<0.95 in men and \\<0.80 in women is considered healthy.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Efficacy Evaluable Population was patients who received ≥4 weeks of study drug and had hip and waist measurements at Baseline and on Week 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Gaining weight without prohibited medication vyvanse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not reporting for scheduled visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliant with investigational product', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.\n\nMiricorilant: Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.\n\nPlacebo: Placebo tablets for once daily oral dosing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43.9', 'spread': '10.50', 'groupId': 'BG000'}, {'value': '47.5', 'spread': '11.78', 'groupId': 'BG001'}, {'value': '45.7', 'spread': '11.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '110.39', 'spread': '20.01', 'groupId': 'BG000'}, {'value': '107.69', 'spread': '25.41', 'groupId': 'BG001'}, {'value': '109.02', 'spread': '22.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Homeostatic model assessment for insulin resistance (HOMA-IR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.687', 'spread': '5.71', 'groupId': 'BG000'}, {'value': '8.463', 'spread': '17.27', 'groupId': 'BG001'}, {'value': '8.577', 'spread': '13.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HOMA-IR = \\[fasting plasma glucose (mg/dL) X fasting insulin (µU/mL)\\]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be ≤1.0 to be considered normal. A score \\>1.9 indicates early insulin resistance and a score \\>2.9 indicates significant insulin resistance.', 'unitOfMeasure': 'HOMA-IR score', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two patients in the placebo group did not have a Baseline HOMA-IR measurement.'}, {'title': 'Waist-to-hip ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.032', 'spread': '0.24', 'groupId': 'BG000'}, {'value': '0.967', 'spread': '0.10', 'groupId': 'BG001'}, {'value': '0.999', 'spread': '0.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Waist-to-hip ratio compares the circumference of the waist to the circumference of the hips. The ratio is calculated by dividing the waist measurement by the hip measurement, using the same units of measurement for both. A waist-to-hip ratio \\<0.95 in men and \\<0.80 in women is considered healthy.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All enrolled patients'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-11', 'size': 1052569, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-21T18:27', 'hasProtocol': True}, {'date': '2022-07-27', 'size': 1473832, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-21T18:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2019-01-24', 'resultsFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-12', 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo', 'timeFrame': 'Baseline Day 1 and Week 12'}, {'measure': 'Number of Patients With One or More Treatment-emergent Adverse Events', 'timeFrame': 'Up to Follow-up Visit (Week 16)'}, {'measure': 'Number of Patients With One or More Treatment-emergent Serious Adverse Events', 'timeFrame': 'Up to Follow-up Visit (up to Week 16)'}, {'measure': 'Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation', 'timeFrame': 'Up to Follow-up Visit (up to Week 16)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Achieving More Than or Equal to 5% Weight Loss', 'timeFrame': 'Baseline Day 1 to Week 12'}, {'measure': 'Change From Baseline in HOMA-IR at Week 12', 'timeFrame': 'Baseline Day 1 and Week 12', 'description': 'HOMA-IR = \\[fasting plasma glucose (mg/dL) X fasting insulin (µU/mL)\\]/405. HOMA-IR is a method to evaluate insulin sensitivity. The HOMA-IR score should be ≤1.0 to be considered normal. A score \\>1.9 indicates early insulin resistance and a score \\>2.9 indicates significant insulin resistance.'}, {'measure': 'Change From Baseline in Waist-to-hip Ratio at Week 12', 'timeFrame': 'Baseline Day 1 and Week 12', 'description': 'Waist-to-hip ratio compares the circumference of the waist to the circumference of the hips. The ratio is calculated by dividing the waist measurement by the hip measurement, using the same units of measurement for both. A waist-to-hip ratio \\<0.95 in men and \\<0.80 in women is considered healthy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antipsychotic-induced weight gain (AIWG)', 'Obesity', 'Weight Gain', 'Mental disorders', 'Schizophrenia', 'Risperidone', 'Quetiapine', 'Olanzapine', 'Bipolar Disorder'], '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 adults with schizophrenia or bipolar disorder 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 or bipolar disorder who are currently taking oral or injectable atypical antipsychotic medication.\n\nPatients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to receive 600 mg miricorilant or placebo for 12 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 or bipolar disorder\n* Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications\n* Must be on a stable dose of medication for 1 month prior to Screening\n* Are able to successfully complete placebo tablet swallow test\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.'}, 'identificationModule': {'nctId': 'NCT03818256', 'acronym': 'GRATITUDE', 'briefTitle': 'A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corcept Therapeutics'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)', 'orgStudyIdInfo': {'id': 'CORT118335-876'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Miricorilant 600 mg', 'description': 'Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.', 'interventionNames': ['Drug: Miricorilant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Miricorilant', 'type': 'DRUG', 'otherNames': ['CORT118335'], 'description': 'Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing', 'armGroupLabels': ['Miricorilant 600 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets for once-daily oral dosing', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72712', 'city': 'Bentonville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Site 143', 'geoPoint': {'lat': 36.37285, 'lon': -94.20882}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Site 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