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

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) vs the coadministration of individual tablets.

NCT Number	NCT07235189
Lead Sponsor	Daiichi Sankyo
Conditions	Healthy Subjects
Enrollment	58 participants
Start Date	2025-10-28
Primary Completion	2026-01-28 (estimated)
Study Completion	2026-01-28 (estimated)
Updated on ClinicalTrials.gov	2026-02-02