NCT07206472Recruiting
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2120 (estimated)
- First submitted
- 25 Sept 2025
- Start date
- 3 Mar 2026
- Primary completion date
- 22 Nov 2028
- Lead sponsor
- Daiichi Sankyo
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07206472
What you commit to
- Study type: Observational
- Planned participants: 2120
- From 3 Mar 2026 to the primary completion date, 22 Nov 2028
- 38 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Vera Cruz Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| Hospital Felicio Rocho Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| Hospital Mater Dei Contorno Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| Clinica Procardio Ltda. Coordinator of this site? Confirm its status | Blumenau | Brazil | Recruiting |
| Universidade de Caxias do Sul (UCS) Coordinator of this site? Confirm its status | Caixias Do Sul | Brazil | Recruiting |
| Hospital e Maternidade Angelina Caron Coordinator of this site? Confirm its status | Campina Grande do Sul | Brazil | Recruiting |
| Pontificia Universidade Catolica do Parana-(PUCPR) Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda Coordinator of this site? Confirm its status | Joinville | Brazil | Recruiting |
| Galileo Medical Research Ltda. Coordinator of this site? Confirm its status | Juiz de Fora | Brazil | Recruiting |
| Hospital Parana - Parana Medical Research Center Coordinator of this site? Confirm its status | Maringá | Brazil | Recruiting |
| Hospital Maternidade e Pronto Socorro Santa Lucia Coordinator of this site? Confirm its status | Pocos de Calda | Brazil | Recruiting |
| Hospital Moinhos de Vento (HMV) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital da Mater Dei Salvador Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Fundação Bahiana de Infectologia Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Hospital E Maternidade Dr. Cristavao da Gama (HMCG) Coordinator of this site? Confirm its status | Santo André | Brazil | Recruiting |
| Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - InCor HCFMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hospital Alemao Oswaldo Cruz (HAOC) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| FGM Clinica Paulista De Doencas Cardiovasculares (IPDC) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Cardial Servicos Medicos Especializados Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Instituto Conceive Ltda Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| BP - A Beneficência Portuguesa de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Instituto de Moléstias Cardiovasculares Tatuí Coordinator of this site? Confirm its status | Tatuí | Brazil | Recruiting |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| The Chinese University of Hong Kong-Prince of Wales Hospital (PWH) Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| The University of Hong Kong/Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| The University of Hong Kong (HKU)-Queen Mary Hospital (QMH) Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| Mahidol University-Ramathibodi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| King Chulalongkorn Memorial Hospital (KCMH) Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Navamindradhiraj University-Vajira Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Phramongkutklao Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Songklanagarind Hospital Coordinator of this site? Confirm its status | Hat Yai | Thailand | Recruiting |
| Faculty of Medicine-Thammasat University Hospital Coordinator of this site? Confirm its status | Khlong Luang | Thailand | Recruiting |
| Khon Kaen University - Queen Sirikit Heart Center of the Northeast Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Recruiting |
| Maharaj Nakhon Chiang Mai University Hospital Coordinator of this site? Confirm its status | Muang Chiang Mai | Thailand | Recruiting |
| Central Chest Institute of Thailand Coordinator of this site? Confirm its status | Muang Nonthaburi | Thailand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.