Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
Study NCT ID:
NCT04753606
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2021-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'study.director@newamsterdampharma.com', 'phone': '+1(305) 627-3081', 'title': 'Study Director', 'organization': 'NewAmsterdam Pharma'}, 'certainAgreement': {'otherDetails': 'After the multicenter publication or 12 months after completion of the study, whichever occurs first, Institution may publish the results of its study data. Institution and PI shall provide sponsor with an advance copy of any proposed communications at least 60 days prior and Sponsor shall have 60 days to review. Sponsor may request (a) the deletion of any Confidential Information, (b) reasonable changes, or (c) a delay for an additional period, not to exceed 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug through week 12', 'description': 'Safety Population included all participants who received at least 1 dose of any study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 17, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 15, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 8, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pelvic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Perineal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Colitis microscopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Bone contusion', 'stats': 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 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'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'OG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'OG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.00', 'spread': '3.502', 'groupId': 'OG000'}, {'value': '-37.97', 'spread': '3.491', 'groupId': 'OG001'}, {'value': '-44.18', 'spread': '3.461', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.96', 'ciLowerLimit': '-44.03', 'ciUpperLimit': '-21.90', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': 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'title': 'LS Mean Percent Change in Apolipoprotein B (ApoB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'OG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'OG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.13', 'spread': '2.593', 'groupId': 'OG000'}, {'value': '-22.40', 'spread': '2.582', 'groupId': 'OG001'}, {'value': '-28.12', 'spread': '2.564', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.26', 'ciLowerLimit': '-25.51', 'ciUpperLimit': '-11.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.657', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.99', 'ciLowerLimit': '-31.22', 'ciUpperLimit': '-16.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.650', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8-Weeks', 'description': 'Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'OG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'OG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.22', 'spread': '20.440', 'groupId': 'OG000'}, {'value': '-34.28', 'spread': '25.623', 'groupId': 'OG001'}, {'value': '-39.25', 'spread': '17.625', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.54', 'ciLowerLimit': '-39.46', 'ciUpperLimit': '-21.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.503', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.03', 'ciLowerLimit': '-44.92', 'ciUpperLimit': '-27.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.488', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}], 'paramType': 'MEAN', 'timeFrame': '8-weeks', 'description': 'Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.'}, {'type': 'SECONDARY', 'title': 'Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'OG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'OG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.50', 'groupId': 'OG000', 'lowerLimit': '-50.3', 'upperLimit': '48.4'}, {'value': '-38.90', 'groupId': 'OG001', 'lowerLimit': '-65.6', 'upperLimit': '66.3'}, {'value': '-44.40', 'groupId': 'OG002', 'lowerLimit': '-70.2', 'upperLimit': '22.5'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.54', 'ciLowerLimit': '-39.46', 'ciUpperLimit': '-21.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.503', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.03', 'ciLowerLimit': '-44.92', 'ciUpperLimit': '-27.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.488', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}], 'paramType': 'MEDIAN', 'timeFrame': '8-Weeks', 'description': 'Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'OG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'OG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.83', 'spread': '3.191', 'groupId': 'OG000'}, {'value': '-34.37', 'spread': '3.179', 'groupId': 'OG001'}, {'value': '-39.86', 'spread': '3.153', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.54', 'ciLowerLimit': '-39.46', 'ciUpperLimit': '-21.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.503', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.03', 'ciLowerLimit': '-44.92', 'ciUpperLimit': '-27.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.488', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8-Weeks', 'description': 'LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'OG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'OG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.62', 'spread': '12.436', 'groupId': 'OG000'}, {'value': '123.92', 'spread': '57.671', 'groupId': 'OG001'}, {'value': '156.41', 'spread': '52.165', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '129.27', 'ciLowerLimit': '110.78', 'ciUpperLimit': '147.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.337', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '164.33', 'ciLowerLimit': '145.90', 'ciUpperLimit': '182.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.306', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}], 'paramType': 'MEAN', 'timeFrame': '8-weeks', 'description': 'Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.'}, {'type': 'SECONDARY', 'title': 'Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'OG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'OG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.90', 'groupId': 'OG000', 'lowerLimit': '-30.3', 'upperLimit': '28.6'}, {'value': '135.40', 'groupId': 'OG001', 'lowerLimit': '-26.4', 'upperLimit': '212.9'}, {'value': '164.95', 'groupId': 'OG002', 'lowerLimit': '55.1', 'upperLimit': '286.3'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '129.27', 'ciLowerLimit': '110.78', 'ciUpperLimit': '147.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.337', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '164.33', 'ciLowerLimit': '145.90', 'ciUpperLimit': '182.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.306', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}], 'paramType': 'MEDIAN', 'timeFrame': '8-Weeks', 'description': 'Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.'}, {'type': 'SECONDARY', 'title': 'LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'OG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'OG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.98', 'spread': '6.620', 'groupId': 'OG000'}, {'value': '122.29', 'spread': '6.585', 'groupId': 'OG001'}, {'value': '157.35', 'spread': '6.538', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '129.27', 'ciLowerLimit': '110.78', 'ciUpperLimit': '147.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.337', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '164.33', 'ciLowerLimit': '145.90', 'ciUpperLimit': '182.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.306', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'mixed model for repeated measures (MMRM) with missing at random assumption'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8-Weeks', 'description': 'LS mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'FG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'FG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '195 participants were screened; out of 195, 120 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'once-daily placebo\n\nObicetrapib: tablets'}, {'id': 'BG001', 'title': 'Obicetrapib 5 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'BG002', 'title': 'Obicetrapib 10 mg', 'description': 'once-daily obicetrapib\n\nObicetrapib: tablets'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '8.77', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '8.13', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '8.48', 'groupId': 'BG002'}, {'value': '61.8', 'spread': '8.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (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': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values', 'classes': [{'categories': [{'measurements': [{'value': '98.6', 'spread': '31.09', 'groupId': 'BG000'}, {'value': '99.2', 'spread': '30.95', 'groupId': 'BG001'}, {'value': '94.2', 'spread': '31.14', 'groupId': 'BG002'}, {'value': '97.33', 'spread': '31.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline LDL-C is defined as the last measurement prior to the first dose of study drug. LDL-C was calculated using the Friedewald Formula.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-26', 'size': 1079797, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-13T14:55', 'hasProtocol': True}, {'date': '2021-07-07', 'size': 6853664, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-13T14:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'placebo tablet made to resemble active'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo-controlled, double-blind, randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2021-02-09', 'resultsFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-10', 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]', 'timeFrame': '8-weeks', 'description': 'Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG\n\n≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),'}, {'measure': 'Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]', 'timeFrame': '8-Weeks', 'description': 'Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \\[Friedewald\\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),'}, {'measure': 'LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]', 'timeFrame': '8-Weeks', 'description': 'LS mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \\[Friedewald\\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),'}, {'measure': 'Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]', 'timeFrame': '8-Weeks', 'description': 'Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).'}, {'measure': 'Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]', 'timeFrame': '8-Weeks', 'description': 'Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).'}, {'measure': 'LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]', 'timeFrame': '8-Weeks', 'description': 'LS Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured directly by preparative ultracentrifugation (PUC).'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change in Apolipoprotein B (ApoB)', 'timeFrame': '8-Weeks', 'description': 'Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.'}, {'measure': 'Median Percent Change in Apolipoprotein B (ApoB)', 'timeFrame': '8-Week', 'description': 'Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.'}, {'measure': 'LS Mean Percent Change in Apolipoprotein B (ApoB)', 'timeFrame': '8-Weeks', 'description': 'Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.'}, {'measure': 'Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'timeFrame': '8-weeks', 'description': 'Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group'}, {'measure': 'Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'timeFrame': '8-Weeks', 'description': 'Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group'}, {'measure': 'LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'timeFrame': '8-Weeks', 'description': 'LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group'}, {'measure': 'Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': '8-weeks', 'description': 'Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.'}, {'measure': 'Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': '8-Weeks', 'description': 'Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.'}, {'measure': 'LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': '8-Weeks', 'description': 'LS mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obicetrapib', 'statin', 'LDL-C', 'cholesterol', 'atherosclerosis'], 'conditions': ['Dyslipidemias', 'High Cholesterol', 'Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '35953719', 'type': 'RESULT', 'citation': 'Nicholls SJ, Ditmarsch M, Kastelein JJ, Rigby SP, Kling D, Curcio DL, Alp NJ, Davidson MH. Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial. Nat Med. 2022 Aug;28(8):1672-1678. doi: 10.1038/s41591-022-01936-7. Epub 2022 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.', 'detailedDescription': 'This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up and a 15-week PK follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LDL-C \\> 70 mg/dL and TG \\< 400 mg/dL,\n* Treated with a high-intensity statin therapy\n\nExclusion Criteria:\n\n* BMI \\> 40 kg/m\n* Significant cardiovascular disease\n* HbA1c \\> 10%\n* Uncontrolled hypertension\n* Active muscle disease\n* GFR \\< 60 ml/min\n* Hepatic dysfunction\n* Anemia\n* History of malignancy\n* Alcohol abuse\n* Treatment with investigational product\n* Treatment with PCSK9\n* Clinically significant condition\n* Known CETP inhibitor allergy'}, 'identificationModule': {'nctId': 'NCT04753606', 'acronym': 'ROSE', 'briefTitle': 'Randomized Study of Obicetrapib as an Adjunct to Statin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'NewAmsterdam Pharma'}, 'officialTitle': 'A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to High-Intensity Statin Therapy', 'orgStudyIdInfo': {'id': 'TA-8995-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'once-daily placebo', 'interventionNames': ['Drug: Obicetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'obicetrapib 5 mg', 'description': 'once-daily obicetrapib', 'interventionNames': ['Drug: Obicetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'obicetrapib 10 mg', 'description': 'once-daily obicetrapib', 'interventionNames': ['Drug: Obicetrapib']}], 'interventions': [{'name': 'Obicetrapib', 'type': 'DRUG', 'otherNames': ['CETP inhibitor'], 'description': 'tablets', 'armGroupLabels': ['Placebo', 'obicetrapib 10 mg', 'obicetrapib 5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute - Huntington Park', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute - Wilshire', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Cardiovascular Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Progressive Medical Research', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'IACT Health', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Premier Healthcare Research LLC', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Institute for Clinical Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakland Medical Research Center', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Diabetes and Endocrinology Consultants, P.C.', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Lillestol Research, LLC', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Metabolic and Atherosclerosis Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44262', 'city': 'Munroe Falls', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summit Research Group, LLC', 'geoPoint': {'lat': 41.1445, 'lon': -81.43983}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Monument Health Clinical Research', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Health Concepts', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '77040', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Juno Research, LL', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Manassas Clinical Research Center', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NewAmsterdam Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}