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

NCT ID: NCT07268625

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-09

Study Completion Date

2026-03-03

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Subjects

Keywords

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Healthy Subjects Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Formulation

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).

Group Type EXPERIMENTAL

Bempedoic acid

Intervention Type DRUG

180 mg film coated tablet administered as FDC or co-administered with ezetimibe

(Component of FDC)

Ezetimibe

Intervention Type DRUG

10 mg tablet administered as FDC or co-administered with bempedoic acid

(Component of FDC)

Atorvastatin

Intervention Type DRUG

40 mg tablet administered as FDC or individually

(Component of FDC)

Reference Formulation

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

Group Type ACTIVE_COMPARATOR

Bempedoic acid

Intervention Type DRUG

180 mg film coated tablet administered as FDC or co-administered with ezetimibe

(Component of FDC)

Ezetimibe

Intervention Type DRUG

10 mg tablet administered as FDC or co-administered with bempedoic acid

(Component of FDC)

Atorvastatin

Intervention Type DRUG

40 mg tablet administered as FDC or individually

(Component of FDC)

Interventions

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Bempedoic acid

180 mg film coated tablet administered as FDC or co-administered with ezetimibe

(Component of FDC)

Intervention Type DRUG

Ezetimibe

10 mg tablet administered as FDC or co-administered with bempedoic acid

(Component of FDC)

Intervention Type DRUG

Atorvastatin

40 mg tablet administered as FDC or individually

(Component of FDC)

Intervention Type DRUG

Other Intervention Names

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Nilemdo® Ezetrol® Sortis®

Eligibility Criteria

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Inclusion Criteria

1. Healthy male and female participants ≥18 and ≤60 years, at the time of signing the informed consent. 2. Body mass index (BMI) ≥18.5 and ≤30.0 kg/m\^2. 3. 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). 4. No clinically relevant diseases captured in medical history. 5. No clinically relevant abnormalities on physical examination. 6. No clinically relevant abnormalities on vital signs. 7. No clinically relevant abnormalities on 12-lead electrocardiogram (ECG). 8. No clinically relevant abnormalities on clinical laboratory tests. 9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above the upper limit of normal range (ULN). 10. 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. 11. Willingness to accept and comply with all study procedures and restrictions. 12. 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).

Exclusion Criteria

A participant is not eligible for the study at Screening if he/she fulfills any of the exclusion criteria as specified in the protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Daiichi Sankyo Contact for Clinical Trial Information

Role: CONTACT

Phone: 908-992-6400

Email: [email protected]

Facility Contacts

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Principal Investigator

Role: primary

Other Identifiers

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2024-519851-27-00

Identifier Type: OTHER

Identifier Source: secondary_id

DSE-BMP-0003-CIS-MA

Identifier Type: -

Identifier Source: org_study_id