NCT06305559

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: NewAmsterdam Pharma · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lipidemia
• Coronary Artery Disease
• Plaque, Atherosclerotic

Interventions

Type	Name	Description
DRUG	obicetrapib 10 mg + ezetimibe 10 mg FDC daily	Active treatment
OTHER	Placebo	Baseline lipid modifying therapy

Timeline

• Start date: 2024-05-16
• Primary completion: 2027-11-01
• Completion: 2028-02-01
• First posted: 2024-03-12
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study