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Coronary AtherosclerosisPhase 3NCT07474649

A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events

A Phase 3 study testing Bempedoic acid, Ezetimibe and Rosuvastatin in people with Coronary Atherosclerosis and Mixed Dyslipidemia, run by Daiichi Sankyo at 12 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bempedoic acid, Ezetimibe and Rosuvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
12 sitesin 3 countries
Study dates
30 Sep 2026to 2 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • In order to be eligible to participate in this trial, a potential participant must meet all of the following criteria:
  • Age ≥18 years
  • Having provided informed consent for participation in this trial
  • Lipid-lowering treatment-naïve
  • Presence of extensive coronary atherosclerosis meeting all of the criteria below:
  • Unequivocal atherosclerosis in ≥5 American Heart Association (AHA) coronary segments (corresponding to a risk equivalent of obstructive coronary artery disease) and coronary artery disease - reporting and data system (CAD-RADS) category 1, 2, or 3
Show all 9Show fewer
  • Not expected to be a candidate for revascularisation during the duration of the trial
  • Untreated LDL-C ≥2.6 mmol/L and ≤4.5 mmol/L (where a diet without pharmacological treatment is considered 'untreated')
  • Able to provide informed consent

Who cannot join

  • A potential participant who meets any of the following criteria will be excluded from participation in this trial:
  • Known or suspected heterozygous or homozygous familial hypercholesterolaemia or familial combined hyperlipidaemia
  • Known contraindication for BA, EZE, atorvastatin, and/or rosuvastatin. A participant with a contraindication for atorvastatin, can be assigned to triple therapy with rosuvastatin, and vice versa.
  • Not expected to remain on a stable dose of high intensity triple therapy for the duration of the trial.
  • History of myocardial infarction, stroke, or peripheral artery disease (PAD), and/or coronary revascularisation (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG])
  • Significant stenosis in the left main artery (≥50%) or proximal LAD artery (≥70%), or 3-vessel coronary artery disease (≥70% stenosis in major branches), clinically indicated for revascularisation
Show all 23Show fewer
  • Known significant liver disease (e.g., positive hepatitis B or hepatitis C serology) or significant hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3 x upper limit of normal [ULN])
  • Known history of gout and/or uric acid levels at Screening ≥6.8 mg/dL
  • Known estimated glomerular filtration rate (eGFR) <40 mL/min/1.73m² and/or receiving dialysis
  • Active malignancy (not including non-melanoma skin cancer)
  • Pregnant or breastfeeding
  • Body mass index (BMI) >35 kg/m²
  • Anticipated life expectancy <52 weeks at the discretion of the local investigator
  • Requiring emergent procedures or having any evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, severe congestive heart failure (New York Heart Association [NYHA] III or IV), or acute pulmonary oedema
  • Suspicion of acute coronary syndrome (where acute myocardial infarction and unstable angina have not been ruled out)
  • Complex congenital heart disease
  • Known or suspected severe valvular heart disease or valvular heart disease anticipated to require intervention within 52 weeks at the discretion of the local investigator
  • Cardiac arrythmia or tachycardia with significant likelihood of resulting in poor PCD-CTA image quality (especially atrial fibrillation or frequent premature beats)
  • Intracoronary stents
  • Prior pacemaker, internal defibrillator, or abandoned lead implantation
  • Prosthetic heart valves
  • Contraindications to contrast media or other medications needed for proper imaging (e.g., beta blockers and nitroglycerin)
  • Use of any experimental or investigational drug within 40 days or 5 half-lives prior to Screening (whichever is longer), or parallel participation in another interventional study

Trial locations and contacts

12 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

12 sites in 3 countries

Germany4 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203

    Ursula Rauch-Kröhnert

  • UKE Hamburg

    Hamburg

    Natalie Arnold

  • Universität Mainz

    Mainz, 55131

    Hell

  • Heidelberg University

    Mannheim, 68167

    Kathrin Weidner

Other trials in Germany

Italy4 sites

  • IRCCS Policlinico San Donato

    Milan, 20097

    Principal Investigator

  • Cardiology, IRCCS San Raffaele Scientific Institute

    Milan, 20132

    Principal Investigator

  • AOU Federico II di Napoli

    Naples, 80131

    Principal Investigator

  • IRCCS Ospedale Sacro Cuore - Don Calabria

    Negrar, 37024

    Principal Investigator

Other trials in Italy

Spain4 sites

  • Hospital Quironsalud Barcelona

    Barcelona, 08023

    Principal Investigator

  • Hospital San Rafael

    Madrid, 28016

    Jose Pablo Robles Ruiz

  • CUN (Clínica Universitaria de Navarra)

    Madrid, 28027

    Garcia de Yébenes

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223

    Esther Merino Lanza

Other trials in Spain

About this study

Official title: Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

Read the detailed description

The primary objective is to evaluate the effectiveness of the triple therapy in reducing plaque burden.

The key secondary objective is to assess the efficacy of the triple therapy by evaluating changes in plaque composition and morphology. HeartFlow is the imaging analysis vendor.

Being tested
Bempedoic acid, Ezetimibe, Rosuvastatin, Atorvastatin
Keywords
Coronary atherosclerosis, Primary non-familial hypercholesterolaemia, Mixed dyslipidaemia, Bempedoic acid, Ezetimibe, Atorvastatin, Rosuvastatin
Medical subject headings
Coronary Artery Disease, Hypercholesterolemia

What participants receive

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

Study groups in NCT07474649
Study groupRoleWhat they receive
Bempedoic acid (BA)/ezetimibe (EZE) fixed dose combination (FDC) with rosuvastatin or atorvastatinExperimentalTreatment-naïve participants with coronary atherosclerosis and primary non-familial hypercholesterolaemia or mixed dyslipidaemia who will receive daily treatment with BA/EZE FDC, together with either 20 mg rosuvastatin or 40 mg atorvastatin.
Receives: Drug: Bempedoic acid; Drug: Ezetimibe; Drug: Rosuvastatin; Drug: Atorvastatin

What is being measured

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

  1. Annualised change in percentage plaque burden (Δ%PB)

    This endpoint will evaluate the effectiveness of the triple therapy in reducing plaque burden (PB).

    Measured: Baseline up to 12 months

Secondary outcomes (16)

  1. Key Secondary: Annualised change in normalised non-calcified plaque volume (PV)

    This endpoint will assess the efficacy of the triple therapy by evaluating changes in plaque composition and morphology.

    Measured: Baseline up to 12 months

  2. Percentage of participants with regression in normalised total plaque volume (TPV), normalised non-calcified PV, and normalised low attenuation PV at EoT (i.e., ΔPV and Δnon-calcified PV, and Δlow-attenuation PV)

    This endpoint will evaluate the potential impact of the triple therapy on total plaque volume (TPV) regression, non-calcified PV regression, and low attenuation PV regression.

    Measured: Baseline up to 12 months

  3. Change in the absolute Agatston coronary artery calcium (CAC) score

    This endpoint will evaluate the potential impact of the triple therapy on coronary calcification. CAC measures the total area and density of calcified plaque in the heart's arteries, ranging from 0 to over 400. A score of 0 indicates no plaque, while higher scores indicate increased risk of cardiovascular events, with >400 indicating extensive disease.

    Measured: Baseline up to 12 months

  4. Annualised ΔTotal Plaque Volume (TPV)

    This endpoint will evaluate the effectiveness of the triple therapy in reducing TPV.

    Measured: Baseline up to 12 months

  5. Percentage of participants with regression in TPV (i.e., negative ΔTPV)

    This endpoint will assess the proportion of participants exhibiting regression in TPV with triple therapy.

    Measured: Baseline up to 12 months

  6. Absolute annualised change in fractional flow reserve derived from computed tomography (FFRCT) of the vessel with the lowest FFR at Baseline

    This endpoint will assess changes in non-invasive coronary flow reserve.

    Measured: Baseline up to 12 months

  7. Absolute annualised change in FFRCT of the average of 3 main epicardial coronary arteries (left anterior descending artery [LAD], circumflex artery [Cx], right coronary artery [RCA])

    This endpoint will assess changes in non-invasive coronary flow reserve.

    Measured: Baseline up to 12 months

  8. Mean absolute changes in atherosclerosis-related biomarker total cholesterol

    This endpoint will evaluate the biochemical impact of triple therapy on critical biomarkers associated with atherosclerosis.

    Measured: Baseline up to 12 months

  9. Mean absolute changes in atherosclerosis-related biomarker low-density lipoprotein cholesterol (LDL-C)

    This endpoint will evaluate the biochemical impact of triple therapy on critical biomarkers associated with atherosclerosis.

    Measured: Baseline up to 12 months

  10. Mean absolute changes in atherosclerosis-related biomarker high-density lipoprotein cholesterol (HDL-C)

    This endpoint will evaluate the biochemical impact of triple therapy on critical biomarkers associated with atherosclerosis.

    Measured: Baseline up to 12 months

  11. Mean absolute changes in atherosclerosis-related biomarker non-high-density lipoprotein cholesterol (non-HDL-C)

    This endpoint will evaluate the biochemical impact of triple therapy on critical biomarkers associated with atherosclerosis.

    Measured: Baseline up to 12 months

  12. Mean absolute changes in atherosclerosis-related biomarkers lipoprotein a (Lp(a)) and apolipoprotein B (apoB)

    This endpoint will evaluate the biochemical impact of triple therapy on critical biomarkers associated with atherosclerosis.

    Measured: Baseline up to 12 months

  13. Mean absolute changes in atherosclerosis-related biomarker high-sensitive C reactive protein (hs-CRP)

    This endpoint will evaluate the biochemical impact of triple therapy on critical biomarkers associated with atherosclerosis.

    Measured: Baseline up to 12 months

  14. Annualised changes in Framingham steatosis index (FSI) and fibrosis-4 (Fib-4)

    This endpoint will assess the potential impact of the triple therapy on measures of liver health.

    Measured: Baseline up to 12 months

  15. Cumulative incidence of adverse events (AEs) under triple therapy during the trial

    This endpoint will monitor and assess adverse events (AEs) under triple treatment.

    Measured: Baseline up to 12 months

  16. Rate of treatment discontinuation during the trial

    This endpoint will to determine the rate and reasons for treatment discontinuation among trial participants receiving triple therapy.

    Measured: Baseline up to 12 months

Timeline

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

  1. First posted16 Mar 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion2 Oct 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
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
103 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07474649
Sponsor's protocol ID
DSE-BMP-0005-CIS-MA
Other IDs
2025-524625-41, 2025
Status last verified
Sep 2026
First submitted
11 Mar 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bempedoic acid, Ezetimibe and Rosuvastatin in people with Coronary Atherosclerosis and Mixed Dyslipidemia, run by Daiichi Sankyo at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daiichi Sankyo Contact for Clinical Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualised change in percentage plaque burden (Δ%PB) (time frame: Baseline up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07474649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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