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NCT Number: NCT07206472

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Hypercholesterolaemia Mixed Dyslipidemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

São Paulo, 05403-000, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients can be enrolled, when they fulfil the following 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.

No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.

Treatment and study plan

Combination of bempedoic acid and ezetimibe

Drug

No drug was administered in this observational study.

Primary outcomes

  1. Incidence of adverse events

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

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

Secondary outcomes

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

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

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

  2. Proportion of patients with level of LDL-C goal attainment

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

    The proportion of patients with level of LDL-C goal attainment at any subsequent data collection time point will be assessed.

  3. Change from baseline in LDL-C levels

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

    Changes over time in LDL-C levels from prior to treatment with bempedoic acid/FDC to any subsequent data collection points will be assessed.

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

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

    Changes over time in plasma levels of other potentially atherosclerotic cardiovascular disease (ASCVD)-modifying cholesterol fragments, namely, TC, apoB, HDL-C, non-HDL-C, TGs and Lp(a) from prior to treatment with bempedoic acid/FDC with ezetimibe to any subsequent data collection point will be assessed.

  5. Change from baseline in the levels of inflammatory marker hsCRP

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

    Changes over time in the levels of inflammatory marker Hs C-reactive Protein (hsCRP) from prior to treatment with bempedoic acid/FDC with ezetimibe to any subsequent data collection point will be assessed.

  6. Change from baseline in uric acid levels

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

    Changes over time in uric acid levels from prior to treatment with bempedoic acid/FDC with ezetimibe to any subsequent data collection point will be assessed.

  7. Incidence of relevant cardiovascular events

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

    The incidence of relevant CV events, including myocardial infarction (MI), unstable angina requiring hospitalization, CABG, PCI, stroke (ischemic and haemorrhagic), TIA , acute peripheral arterial occlusion, other arterial revascularization procedures, all-cause death, and CV-death will be assessed.

  8. Adverse effects related to lipid-modifying treatments (LMTs) other than bempedoic acid/FDC with ezetimibe

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

    Adverse effects related to lipid-modifying treatment (LMT) other than bempedoic acid/FDC with ezetimibe, including insufficient lipid lowering efficacy, laboratory abnormalities, muscle-associated symptoms, new onset and/or worsening of existing diabetes mellitus, reduced kidney function, drug-drug interaction assessed by the physician, and non-compliance assessed by the physician will be assessed.

  9. Use of lipid modifying therapies prior or concomitantly to receiving bempedoic acid/FDC with ezetimibe

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

    The use of LMTs prior or concomitantly to receiving bempedoic acid/FDC with ezetimibe (including combination treatments) will be assessed.

  10. Treatment duration of bempedoic acid/FDC with ezetimibe

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

    Bempedoic acid/FDC with ezetimibe treatment parameters such as treatment duration by therapy, dosage, prescription intervals, permanent discontinuations, switches and reasons for these will be assessed.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Multi-national, Non-interventional Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia

Acronym: Musashi

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Oct 3, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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