NCT07206472

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,560

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Mar 2029

First Submitted

Initial submission to the registry

September 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

March 3, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

September 25, 2025

Last Update Submit

March 24, 2026

Conditions

Primary HypercholesterolaemiaMixed Dyslipidemia

Keywords

Primary hypercholesterolemiaMixed dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Adverse events (AEs) will be collected after signed informed consent and initiation of bempedoic acid/FDC with ezetimibe.

    From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy

Secondary Outcomes (10)

  • Cardiovascular (CV) risk of patients treated with bempedoic acid/FDC with ezetimibe using 2019 ESC/EAS guidelines risk classification

    From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy

  • Proportion of patients with level of LDL-C goal attainment

    From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy

  • Change from baseline in LDL-C levels

    From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy

  • Change from baseline in plasma levels of other potentially ASCVD-modifying cholesterol fragments

    From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy

  • Change from baseline in the levels of inflammatory marker hsCRP

    From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy

  • +5 more secondary outcomes

Study Arms (1)

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.

Drug: Combination of bempedoic acid and ezetimibe

Interventions

Combination of bempedoic acid and ezetimibeDRUG

No drug was administered in this observational study.

Bempedoic acid/FDC with ezetimibe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes adult patients diagnosed with primary hypercholesterolemia or mixed dyslipidemia treated by specialized as well as non-specialized physicians in hospitals and office-based centers from six countries (Brazil, Hong Kong, South Korea, Taiwan, Thailand, and Vietnam).

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - InCor HCFMUSP

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Interventions

Ezetimibe

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Global Team Lead

    Daiichi Sankyo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2025

First Posted

October 3, 2025

Study Start

March 3, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)