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Can a gentler cholesterol combo prevent diabetes in heart patients?

NCT ID NCT05579626

Disease control Sponsor: Seung-Whan Lee, M.D., Ph.D. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 4,000 adults with prediabetes and heart disease to see if a low-intensity statin combined with ezetimibe is better than a high-intensity statin alone at preventing new diabetes. Participants will be followed to track diabetes development and heart health. The goal is to find a safer way to manage cholesterol without raising diabetes risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men or women between the ages of 18 and 75 years who have prediabetes \- Prediabetes consists of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or HbA1c 1. IFG: fasting plasma glucose (FPG) 100 to 125 mg/dL 2. IGT: 2 hours post-load glucose on the 75g OGTT (oral glucose tolerance test) 140 to 199 mg/dL 3. HbA1c: 5.7 to 6.4% 2. Patient requiring high-intensity statin due to high risk of a future cardiovascular event if at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening (Clinically documented ASCVD) * acute coronary syndrome (MI or unstable angina) * stable angina * coronary revascularization (PCI, CABG, and other arterial revascularization procedure) * stroke or TIA * peripheral arterial disease (\<0.9 performed by a vascular lab or angiogram (including CTA) showing ≥ 50%) * ThoracoAbdominal Aortic Aneurysm * Unequivocally documented ASCVD on imaging * significant plaque on coronary angiography on CT (mild, moderate, severe coronary artery disease) * significant plaque on carotid ultrasound (mild, moderate, severe carotid disease) 3. Patients who have never taken a statin or who do not have problems adhering to statin therapy 4. Patient must have been on a stable diet prior to randomization and willing to follow the NCEP (national Cholesterol Education Program) TLC (therapeutic lifestyle changes) diet, or equivalent diet, throughout the study. 5. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: 1. Patient's pregnant or breast-feeding or child-bearing potential. 2. Concomitant administration of potent inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins). 3. Chronic kidney disease (eGFR\<30 ml/min/1.73m2) or dialysis-dependent renal failure 4. Uncontrolled hypothyroidism. 5. Personal or family history of hereditary muscular disorders. 6. History of muscular toxicity with a statin 7. Alcoholism. 8. Hypersensitivity to any of statin and ezetimibe. 9. Hemodynamic unstable conditions at the time of inclusion: cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, or congestive heart failure (New York Heart Association class IV). 10. Any history of hemorrhagic stroke or intracranial hemorrhage within the past 6 months 11. Any surgery requiring discontinuation of statin and/or ezetimibe is planned within 6 months after randomization 12. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer. 13. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. 14. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal) or (Total bilirubin\> 2 times upper limit of normal). 15. Life expectancy \< 1 years for any non-cardiac or cardiac causes 16. Unwillingness or inability to comply with the procedures described in this protocol. 17. People who have previously been diagnosed with diabetes and are taking lifestyle modification and oral hypoglycemic agent (OHA) or insulin (In woman, gestational diabetes is included)

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Conditions

The condition(s) this trial relates to.

atherosclerotic cardiovascular disease glucose intolerance prediabetes syndrome diabetes mellitus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ASCVD Pre-diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

  • Bycheon Sejong Hospital

    Bucheon-si, South Korea

  • Catholic University of Korea, Seoul ST. Mary's Hospital.

    Seoul, South Korea

  • Chonnam National University Hospital

    Gwangju, South Korea

  • Chungbuk National University Hospital

    Cheonju, South Korea

  • Chungnam National University Hospital

    Jungnam, South Korea

  • Chungnam National University Sejong Hospital

    Daejeon, South Korea

  • Daegu Catholic University Medical Center

    Daegu, South Korea

  • Dong-A Medical Center

    Pusan, South Korea

  • Ewha womans university seoul hospital

    Seoul, South Korea

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • Gangneung Asan Hospital

    Gangneung, South Korea

  • Gangwon National University Hospital

    Chuncheon, South Korea

  • Gyeongsang National University Changwon Hospital

    Changwon, South Korea

  • Gyeongsang National University Hospital

    Jinju, South Korea

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, South Korea

  • Inje University Busan Paik Hospital

    Pusan, South Korea

  • Inje University Haeundae Paik Hospital

    Haeundae, South Korea

  • Jeju National University Hospital

    Jeju City, South Korea

  • Kangdong Sacred Heart Hospital

    Seoul, South Korea

  • Keimyung University Dongsan Medical Center

    Daegu, South Korea

  • Konyang University Hospital

    Daejeon, South Korea

  • Korea University Anam Hospital

    Seoul, South Korea

  • Kosin University Gospel Hospital

    Pusan, South Korea

  • Pusan National University Yangsan Hospital

    Pusan, South Korea

  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital

    Seoul, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, South Korea

  • Ulsan university hospital

    Ulsan, South Korea

  • VHS Medical Center

    Seoul, South Korea

  • Yungnam universury Hospital

    Daegu, South Korea

  • the Catholic University of Korea, Daejeon St. Mary'S Hospital

    Daejeon, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.