Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06305559
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2024-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D058226', 'term': 'Plaque, Atherosclerotic'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind set-up; post randomization LDL values are not provided to sites (alert triggers are programmed for urgent follow-up)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• To evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) daily on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months.', 'timeFrame': '18 months', 'description': 'Total plaque comparison measured by CCTA'}], 'secondaryOutcomes': [{'measure': 'Absolute change from baseline to 18 months in total NCPV in all major epicardial coronary arteries, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo.', 'timeFrame': '18 Months', 'description': 'Total change in NCPV as measured by CCTA'}, {'measure': 'Percent change from baseline to 18 months in LDL-C in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared to placebo.', 'timeFrame': '18 Months', 'description': 'Change in LDL-C levels measured by central lab'}, {'measure': 'Percent change from baseline to 18 months in non-calcified coronary atherosclerotic plaque volume in the most diseased coronary segment (NCPVMD), as measured by CCTA, in participants treated with FDC therapy vs placebo', 'timeFrame': '18 Months', 'description': 'Percent change in plaque volume in most diseased coronary arteries measured by CCTA'}, {'measure': 'Absolute change from baseline to 18 months in NCPVMD, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo.', 'timeFrame': '18 Months', 'description': 'Absolute change in plaque volume in most diseased coronary arteries measured by CCTA'}, {'measure': 'Change in perivascular fat attenuation index (FAI), FAI score and its age- and gender specific centile in the principal epicardial coronary arteries as measured by CCTA in participants treated with FDC therapy compared with placebo.', 'timeFrame': '18 Months', 'description': 'Changes in coronary arterial fat composition measured by CCTA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lipidemia', 'Coronary Artery Disease', 'Plaque, Atherosclerotic']}, 'referencesModule': {'references': [{'pmid': '40683616', 'type': 'DERIVED', 'citation': 'McCarthy CP, Ballantyne CM, Blankstein R, Budoff MJ, Ditmarsch M, Gibson CM, Kastelein JJP, Navar AM, Nicholls SJ, Ray KK, Shirodaria C, Williams MC, Januzzi JL Jr. Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics. Am Heart J. 2025 Dec;290:325-338. doi: 10.1016/j.ahj.2025.07.012. Epub 2025 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting serum LDL-C ≥70 mg/dL (≥1.81 mmol/L)\n* Evaluable non-calcified plaque of at least 75 mm3 in the major epicardial coronary arteries\n* BMI 18-40, inclusive\n* Max tolerated lipid modifying therapy\n* Estimated glomerular filtration rate ≥40 mL/min/1.73 m2\n\nExclusion Criteria:\n\n* HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening\n* Contraindications for CCTA\n* History of coronary artery bypass graft\n* Active liver disease'}, 'identificationModule': {'nctId': 'NCT06305559', 'acronym': 'REMBRANDT', 'briefTitle': 'A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque', 'organization': {'class': 'INDUSTRY', 'fullName': 'NewAmsterdam Pharma'}, 'officialTitle': 'A Placebo-controlled, Double-blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib/Ezetimibe Fixed Dose Combination Daily on Coronary Plaque Characteristics in Participants With Atherosclerotic Cardiovascular Disease on Coronary CT Angiography (REMBRANDT Trial)', 'orgStudyIdInfo': {'id': 'OBEZ-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obicetrapib/Ezetimibe', 'description': 'obicetrapib 10 mg + ezetimibe 10 mg FDC daily', 'interventionNames': ['Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo on top of baseline lipid modifying therapy', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'obicetrapib 10 mg + ezetimibe 10 mg FDC daily', 'type': 'DRUG', 'otherNames': ['FDC'], 'description': 'Active treatment', 'armGroupLabels': ['Obicetrapib/Ezetimibe']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Baseline lipid modifying therapy', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Director', 'role': 'CONTACT', 'email': 'eduardom@ngmresearch.com', 'phone': '305-828-9100'}], 'facility': 'NGMR', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}], 'centralContacts': [{'name': 'Global Clinical Trial Lead', 'role': 'CONTACT', 'email': 'shayleen.vanvuuren@fortrea.com', 'phone': '+27 82 495 9889'}, {'name': 'Claudia Forkel', 'role': 'CONTACT', 'phone': '+49 151 64549618'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NewAmsterdam Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}