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Primary HypercholesterolaemiaMusashiNCT07206472

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

An observational study of Primary Hypercholesterolaemia and Mixed Dyslipidemia, run by Daiichi Sankyo at 38 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Combination of bempedoic acid and ezetimibe
How many people
2,120 participants
Where
38 sitesin 3 countries
Study dates
3 Mar 2026to 31 Dec 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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, and Thailand).

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.

Trial locations and contacts

38 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Daiichi Sankyo Contact for Clinical Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

38 sites in 3 countries

Brazil23 sites, 23 recruiting

  • Hospital Mater Dei Contorno

    Belo Horizonte, 30110-064

    Principal Investigator

    Recruiting

  • Hospital Felício Rocho

    Belo Horizonte, 30110-934

    Principal Investigator

    Recruiting

  • Hospital Vera Cruz

    Belo Horizonte, 30190-130

    Principal Investigator

    Recruiting

  • Clinica Procardio Ltda.

    Blumenau, 89010-500

    Principal Investigator

    Recruiting

  • Universidade de Caxias do Sul (UCS)

    Caixias Do Sul, 95070-561

    Principal Investigator

    Recruiting

  • Hospital e Maternidade Angelina Caron

    Campina Grande do Sul, 83434-286

    Principal Investigator

    Recruiting

  • Pontificia Universidade Catolica do Parana-(PUCPR)

    Curitiba, 80215-901

    Principal Investigator

    Recruiting

  • CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa LTDA

    Joinville, 89204-251

    Principal Investigator

    Recruiting

  • Galileo Medical Research Ltda.

    Juiz de Fora, 18270-170

    Principal Investigator

    Recruiting

  • Hospital Parana - Parana Medical Research Center

    Maringá, 87015-000

    Principal Investigator

    Recruiting

  • Hospital Maternidade e Pronto Socorro Santa Lucia

    Pocos de Calda, 37706-106

    Principal Investigator

    Recruiting

  • Hospital Moinhos de Vento (HMV)

    Porto Alegre, 90035-902

    Principal Investigator

    Recruiting

  • Fundacao Bahiana de Infectologia

    Salvador, 40110-060

    Principal Investigator

    Recruiting

  • Hospital da Mater Dei Salvador

    Salvador, 40221-500

    Principal Investigator

    Recruiting

  • Hospital E Maternidade Dr. Cristavao da Gama (HMCG)

    Santo André, 09030-010

    Principal Investigator

    Recruiting

  • BP - A Beneficencia Portuguesa de Sao Paulo

    São Paulo, 01323-001

    Principal Investigator

    Recruiting

  • Hospital Alemao Oswaldo Cruz (HAOC)

    São Paulo, 01323-020

    Principal Investigator

    Recruiting

  • Instituto Conceive Ltda

    São Paulo, 04005-004

    Principal Investigator

    Recruiting

  • Cardial Servicos Medicos Especializados

    São Paulo, 04039-000

    Principal Investigator

    Recruiting

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

    São Paulo, 05403-000

    Principal Investigator

    Recruiting

  • Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina

    São Paulo, 05403-000

    Principal Investigator

    Recruiting

  • FGM Clinica Paulista De Doencas Cardiovasculares (IPDC)

    São Paulo

    Principal Investigator

    Recruiting

  • Instituto de Molestias Cardiovasculares Tatui

    Tatuí, 18270-170

    Principal Investigator

    Recruiting

Other trials in Brazil

Thailand10 sites, 10 recruiting

  • King Chulalongkorn Memorial Hospital (KCMH)

    Bangkok

    Principal Investigator

    Recruiting

  • Mahidol University-Ramathibodi Hospital

    Bangkok

    Principal Investigator

    Recruiting

  • Navamindradhiraj University-Vajira Hospital

    Bangkok

    Principal Investigator

    Recruiting

  • Phramongkutklao Hospital

    Bangkok

    Principal Investigator

    Recruiting

  • Siriraj Hospital

    Bangkok

    Principal Investigator

    Recruiting

  • Songklanagarind Hospital

    Hat Yai

    Principal Investigator

    Recruiting

  • Faculty of Medicine-Thammasat University Hospital

    Khlong Luang

    Principal Investigator

    Recruiting

  • Khon Kaen University - Queen Sirikit Heart Center of the Northeast

    Khon Kaen

    Principal Investigator

    Recruiting

  • Maharaj Nakhon Chiang Mai University Hospital

    Muang Chiang Mai

    Principal Investigator

    Recruiting

  • Central Chest Institute of Thailand

    Muang Nonthaburi

    Principal Investigator

    Recruiting

Other trials in Thailand

Hong Kong5 sites, 5 recruiting

  • Princess Margaret Hospital

    Hong Kong

    Principal Investigator

    Recruiting

  • Queen Elizabeth Hospital

    Hong Kong

    Principal Investigator

    Recruiting

  • The Chinese University of Hong Kong-Prince of Wales Hospital (PWH)

    Hong Kong

    Principal Investigator

    Recruiting

  • The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)

    Hong Kong

    Principal Investigator

    Recruiting

  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong

    Principal Investigator

    Recruiting

Other trials in Hong Kong

About this study

Official 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

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.

Read the detailed description

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).

Being tested
Combination of bempedoic acid and ezetimibe
Keywords
Primary hypercholesterolemia, Mixed dyslipidemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination of bempedoic acid and ezetimibeDrug

    No drug was administered in this observational study.

Study groups in NCT07206472
Study groupRoleWhat they receive
Bempedoic acid/FDC with ezetimibeAdult 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.
Receives: Drug: Combination of bempedoic acid and ezetimibe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

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

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

Secondary outcomes (10)

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

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

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

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

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

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

  3. Change from baseline in LDL-C levels

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

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

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

    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.

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

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

    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.

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

  6. Change from baseline in uric acid levels

    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.

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

  7. Incidence of relevant cardiovascular events

    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.

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

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

    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.

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

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

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

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

  10. Treatment duration of bempedoic acid/FDC with ezetimibe

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start3 Mar 2026
  3. Primary completion22 Nov 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07206472
Sponsor's protocol ID
DS-ASCAHQ-BMP-HC001
Acronym
Musashi
Status last verified
Oct 2026
First submitted
25 Sep 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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