Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2026-03-03

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Daiichi Sankyo

Treatments:

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Atorvastatin
Ezetimibe