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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obicetrapib/Ezetimibe | Experimental | obicetrapib 10 mg + ezetimibe 10 mg FDC daily |
|
| Placebo | Placebo Comparator | Placebo on top of baseline lipid modifying therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| obicetrapib 10 mg + ezetimibe 10 mg FDC daily | Drug | Active treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| • 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. | Total plaque comparison measured by CCTA | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Total change in NCPV as measured by CCTA | 18 Months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGMR | Hialeah | Florida | 33016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40683616 | Derived | 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. |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003324 | Coronary Artery Disease |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Double blind set-up; post randomization LDL values are not provided to sites (alert triggers are programmed for urgent follow-up)
| Placebo | Other | Baseline lipid modifying therapy |
|
Change in LDL-C levels measured by central lab |
| 18 Months |
| 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 | Percent change in plaque volume in most diseased coronary arteries measured by CCTA | 18 Months |
| 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. | Absolute change in plaque volume in most diseased coronary arteries measured by CCTA | 18 Months |
| 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. | Changes in coronary arterial fat composition measured by CCTA | 18 Months |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |