NCT07474649

A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events

Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

Detailed description

The primary objective is to evaluate the effectiveness of the triple therapy in reducing plaque burden. The key secondary objective is to assess the efficacy of the triple therapy by evaluating changes in plaque composition and morphology.

Conditions

• Coronary Atherosclerosis
• Mixed Dyslipidemia
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Bempedoic acid	FDC: 180 mg
DRUG	Ezetimibe	FDC: 10 mg
DRUG	Rosuvastatin	20 mg dose
DRUG	Atorvastatin	40 mg dose

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-06-01
• Completion: 2028-10-02
• First posted: 2026-03-16
• Last updated: 2026-03-19