Clinical Trial

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin

Completed Phase 1
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Summary
Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles. Triple combination therapies, targeting multiple mechanisms of cholesterol metabolism simultaneously, have demonstrated superior LDL-C reduction and better achievement of guideline recommended LDL-C goals. Additionally, combining treatments into a single regimen can improve patient adherence and compliance, further enhancing clinical outcomes. This study will test the bioequivalence of a test fixed dose combination (FDC) product versus the co-administered individual reference products.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-12-04; most recent amendment 2026-02-26.
Status change: Active, Not Recruiting → Completed 2026-02-26
Status change: Recruiting → Active, Not Recruiting 2026-01-29
Status change: Not Yet Recruiting → Recruiting 2025-12-11
Trial Details
NCT Number NCT07268625
Lead Sponsor Daiichi Sankyo
Conditions Healthy Subjects
Enrollment 58 participants
Start Date 2025-12-09
Primary Completion 2026-02-24 (estimated)
Study Completion 2026-02-24 (estimated)
Updated on ClinicalTrials.gov 2026-02-27