drugset / Trial / NCT06305559

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

NCT06305559

Phase 3 Active not recruiting 300 enrolled NewAmsterdam Pharma
RandomizedParallel-groupQuadruple-blindPrevention

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).

Timeline

Start
2024-05-16
Primary completion
2027-11
Completion
2028-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg
Subject Obicetrapib Small molecule 10 mg