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

NCT07235189 | Completed Phase 1

• 2 other identifiers: DSE-BMP-0001-CIS-MA2024-519849-29-00
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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) vs the coadministration of individual tablets.

Conditions

Healthy Subjects

Keywords

Healthy Subjects; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic Parameter Area Under the Curve (AUC)

  Area under the curve (AUC) from time of dosing (t=0h) to time 72 hours (AUC72h) or AUC from time of dosing (t=0h) to the time of last measurable (non-zero) concentration (AUClast) will be assessed using noncompartmental methods.

  Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

• Maximum Observed Concentration (Cmax)

  Maximum observed concentration will be assessed.

  Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

Secondary Outcomes (6)

• Pharmacokinetic Parameters (AUCinf)

  Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

• Pharmacokinetic Parameters (AUClast/AUCinf)

  Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

• Pharmacokinetic Parameter Time to Reach Maximum Observed Concentration (Tmax)

  Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

• Pharmacokinetic Parameter Terminal Half-life (t1/2)

  Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

• Pharmacokinetic Parameter First Order Rate Constant Associated With The Terminal Portion of the Concentration-Time Curve (Kel)

  Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

Study Arms (2)

Test Formulation

EXPERIMENTAL

Healthy participants who are randomized to receive the fixed dose triplet combination with bempedoic acid 180 mg/ezetimibe 10 mg/atorvastatin 40 mg (test formulation).

Drug: Bempedoic acid; Drug: Ezetimibe; Drug: Atorvastatin

Reference Formulation

ACTIVE COMPARATOR

Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg + ezetimibe 10 mg + atorvastatin 40 mg (reference formulation).

Drug: Bempedoic acid; Drug: Ezetimibe; Drug: Atorvastatin

Interventions

Bempedoic acid DRUG

180 mg film coated tablet administered individually or as FDC (Component of FDC)

Also known as: Nilemdo®

Reference Formulation; Test Formulation

Ezetimibe DRUG

10 mg tablet administered individually or as FDC (Component of FDC)

Also known as: Ezetrol®

Reference Formulation; Test Formulation

Atorvastatin DRUG

40 mg tablet administered individually or as FDC (Component of FDC)

Also known as: Sortis®

Reference Formulation; Test Formulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female participants ≥18 and ≤60 years, at the time of signing the informed consent.
• Body mass index (BMI) ≥18.5 and ≤30.0 kg/m\^2.
• Female participants of childbearing potential agree to undergo pregnancy tests, and if with a non-vasectomized nor infertile male partner, agree to use an appropriate method of contraception (i.e., abstinence, hormonal, intrauterine device, bilateral tubal occlusion).
• No clinically relevant diseases captured in medical history.
• No clinically relevant abnormalities on physical examination.
• No clinically relevant abnormalities on vital signs.
• No clinically relevant abnormalities on 12-lead electrocardiogram (ECG).
• No clinically relevant abnormalities on clinical laboratory tests.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above the upper limit of normal range (ULN).
• Estimated renal creatinine clearance (CrCl) above the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m\^2.
• Willingness to accept and comply with all study procedures and restrictions.
• Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
• Ability to comprehend and willingness to freely sign the informed consent.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Research Site

Porto, 4250-449, Portugal

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: October 28, 2025
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)