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A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia

NCT ID: NCT07206472

Last Updated: 2025-12-24

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

NOT_YET_RECRUITING

Total Enrollment

2560 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-30

Study Completion Date

2029-03-01

Brief Summary

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There is limited efficacy and safety data of bempedoic acid or its fixed dose combination (FDC) with ezetimibe in Asian and Latin American patients. This non-interventional study (NIS) will be conducted to characterize the risks and benefits of bempedoic acid or FDC with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.

Detailed Description

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The primary objective of this study is to describe patient characteristics and evaluate adverse drug reactions (ADRs) that occurred since initiation of bempedoic acid/FDC with ezetimibe and adverse events (AEs) collected after signed informed consent and initiation of bempedoic acid/FDC with ezetimibe in a regular clinical care setting in patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia during 1-year follow-up.

The secondary objectives are defined as the assessment of the cardiovascular risk, rate, level of LDL-C goal attainment, changes over time in LDL-C levels, inflammatory markers, and uric acid levels from prior to treatment with bempedoic acid/FDC, and adverse events (AEs)/adverse drug reactions (ADRs).

Conditions

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Primary Hypercholesterolaemia Mixed Dyslipidemia

Keywords

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Primary hypercholesterolemia Mixed dyslipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bempedoic acid/FDC with ezetimibe

Adult participants who were diagnosed with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia and treated with bempedoic acid/fixed dose combination (FDC) with ezetimibe in a regular clinical care setting.

Combination of bempedoic acid and ezetimibe

Intervention Type DRUG

No drug was administered in this observational study.

Interventions

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Combination of bempedoic acid and ezetimibe

No drug was administered in this observational study.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent to participate.
* At least 18 years of age.
* Patients suffering from documented primary hypercholesterolemia or mixed dyslipidaemia treated or intended to be treated with bempedoic acid/ FDC with ezetimibe at the discretion of the physician are appropriate for participation in the observation.
* For patients who are treated with bempedoic acid/FDC with ezetimibe prior to signed informed consent, initiation of bempedoic acid/FDC with ezetimibe must be within a maximum of three months prior to inclusion.
* No contraindications exist according to the SmPC of bempedoic acid/FDC with ezetimibe.
* No concurrent participation in an interventional study (simultaneous participation in other non-interventional study is possible)
* Life expectancy \> 1 year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Team Lead

Role: STUDY_DIRECTOR

Daiichi Sankyo

Central Contacts

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Daiichi Sankyo Contact for Clinical Trial Information

Role: CONTACT

Phone: 908-992-6400

Email: [email protected]

Other Identifiers

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DS-ASCAHQ-BMP-HC001

Identifier Type: -

Identifier Source: org_study_id