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A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque
Sponsor: NewAmsterdam Pharma
Summary
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).
Official title: 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)
Key Details
Gender
All
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-05-16
Completion Date
2028-02
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Active treatment
Placebo
Baseline lipid modifying therapy
Locations (1)
NGMR
Hialeah, Florida, United States