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New cholesterol drug MK-0616 takes on old favorites in Head-to-Head trial

NCT ID NCT06450366

Disease control Sponsor: Merck Sharp & Dohme LLC 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new drug called MK-0616 (enlicitide) to see if it lowers 'bad' LDL cholesterol better than current pills (ezetimibe, bempedoic acid, or both). About 300 adults with high cholesterol and heart disease risk took part. The main goal was to check cholesterol reduction after 8 weeks and ensure the drug is safe.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

301 people

The number who actually took part.

Started

Jul 2024

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Has either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event * Has fasted lipid values (evaluated by the central laboratory) at Visit 1 (Screening) as follows: a) history of a major ASCVD event with LDL-C ≥55 mg/dL (≥1.42 mmol/L) OR b) No history of a major ASCVD event with low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL (≥1.81 mmol/L) * Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy \[LLT\]) * Is on a stable dose of all background LLTs with no planned medication or dose changes during the study * Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent Exclusion Criteria: * Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH * Has New York Heart Association class IV heart failure, or last known left ventricular ejection fraction ≤25% by any imaging method, or had a heart failure hospitalization within 3 months before Visit 1 (Screening) * Participants with a history of tendon disorder or tendon rupture * Participants with a history of gout * Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program * Was previously treated/is being treated with certain other cholesterol lowering medications, including ezetimibe, bempedoic acid, or protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

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

Hypercholesterolemia

Contacts and locations

Locations

  • Assuta Beersheba MC ( Site 0704)

    Beersheba, 8489507, Israel

  • Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 0901)

    London, England, EC1M 6BQ, United Kingdom

  • CIPREC-CIPREC Sede Arenales ( Site 1000)

    Buenos Aires, Buenos Aires F.D., C1061AAS, Argentina

  • Cambridge Cardiac Care Centre ( Site 1603)

    Cambridge, Ontario, N1R 6V6, Canada

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0404)

    Taoyuan, 33305, Taiwan

  • Clinical Trials Research ( Site 1509)

    Lincoln, California, 95648, United States

  • Diex Recherche Trois-Rivieres ( Site 1602)

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • EAP Sardenya ( Site 0800)

    Barcelona, 08025, Spain

  • Fundacion Estudios Clinicos ( Site 1001)

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Healthcare Research Network - Chicago ( Site 1507)

    Flossmoor, Illinois, 60422, United States

  • Hospices Civils de Lyon - Hopital Louis Pradel ( Site 0501)

    Bron, Rhone, 69677, France

  • Hospital San Rafael de Coruna ( Site 0805)

    A Coruña, La Coruna, 15006, Spain

  • Hospital Universitari Vall d'Hebron ( Site 0803)

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 0801)

    Málaga, Andalusia, 29010, Spain

  • Hospital de Figueres ( Site 0804)

    Figueres, Gerona, 17600, Spain

  • Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 0505)

    Montpellier, Herault, 34090, France

  • Hôpital Bichat - Claude-Bernard ( Site 0504)

    Paris, 75018, France

  • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes-CIC Endocrinology-Diabetology-Nutrition ( Sit

    Nantes, Loire-Atlantique, 44093, France

  • Institut de Cardiologie de Montreal ( Site 1604)

    Montreal, Quebec, H1T 1C8, Canada

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002)

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • L-MARC Research Center ( Site 1501)

    Louisville, Kentucky, 40213, United States

  • Meir Medical Center. ( Site 0703)

    Kfar Saba, 4428164, Israel

  • National Cheng Kung University Hospital-Internal Medicine ( Site 0403)

    Tainan, 704, Taiwan

  • National Institute for Health Research UCLH Clinical Research Facility ( Site 0908)

    London, London, City of, NW1 2PG, United Kingdom

  • National Taiwan University Hospital ( Site 0400)

    Taipei, 10002, Taiwan

  • North York Diagnostic and Cardiac Centre ( Site 1605)

    North York, Ontario, M6B 3H7, Canada

  • Piedmont Research Partners ( Site 1506)

    Fort Mill, South Carolina, 29707, United States

  • Rainier Clinical Research Center ( Site 1502)

    Renton, Washington, 98057, United States

  • Rambam Health Care Campus ( Site 0700)

    Haifa, 3109601, Israel

  • Royal Free Hospital ( Site 0900)

    London, England, NW3 2QG, United Kingdom

  • Taipei Veterans General Hospital-Department of Medicine ( Site 0402)

    Taipei, 11217, Taiwan

  • The Medical Arts Health Research Group ( Site 1606)

    Vancouver, British Columbia, V7M 2H4, Canada

  • Velocity Clinical Research Rockville ( Site 1503)

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research, Gulfport ( Site 1505)

    Gulfport, Mississippi, 39503, United States

  • Yitzhak Shamir Medical Center. ( Site 0702)

    Beer Yaakov, 70300, Israel

More trials for these conditions

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