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New drug duo aims to tackle stubborn heart risk factor

NCT ID NCT07614984

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 15 times

Summary

This Phase 2 trial tests an experimental drug called MK-7262, alone or with another drug called enlicitide, in 750 adults with high levels of lipoprotein(a) – a genetic risk factor for heart disease. The study compares these drugs to a placebo to see if they can safely lower both Lp(a) and LDL cholesterol over 8 weeks. Participants must already be on a stable statin dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-7262 (also known as HRS-5346) and enlicitide decanoate (also known as MK-0616)
What this could lead to
If successful, this could lead to a new treatment option for people with high lipoprotein(a), a genetic risk factor for heart disease, by lowering both Lp(a) and LDL cholesterol.
What could go wrong
This is an early Phase 2 trial, so it's not yet proven to work or be safe. The results may not apply to everyone, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 750 people

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

Started

Jun 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

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: The main inclusion criteria include but are not limited to the following: * Has Lp(a) ≥ 150 nmol/L * Is receiving an optimized and stable dose of statin for ≥ 30 days with no planned additions, dose changes, or discontinuations through the duration of the study Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH * Has a history of class IV heart failure, severe ventricular systolic dysfunction, uncontrolled ventricular arrhythmia, markedly prolonged corrected QT interval, untreated hypertension, or a recent coronary, cerebrovascular, or peripheral ischemic event or arterial revascularization * Has human immunodeficiency virus infection, unless the infection is controlled (i.e. undetectable viral load) * Has an active hepatitis C virus infection or active or chronic hepatitis B virus infection * Has a history of nephrotic syndrome * Has severe renal insufficiency * Has received certain therapies in the prohibited timeframe as specified in the protocol * Has active or chronic hepatobiliary or hepatic disease * Has poorly controlled Type 1 or Type 2 diabetes

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Get notified about this study

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As listed by the trial registrant

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

Lipoprotein(A)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    54 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AMR Clinical Mobile ( Site 0149)

    RECRUITING

    Mobile, Alabama, 36608, United States

  • Advanced Cardiovascular - Alexander City ( Site 0158)

    RECRUITING

    Alexander City, Alabama, 35010, United States

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk ( Site 1101)

    RECRUITING

    Dordrecht, South Holland, 3318 AT, Netherlands

  • Ambulantes Herzzentrum Kassel ( Site 0721)

    RECRUITING

    Kassel, Hesse, 34121, Germany

  • Antonius Ziekenhuis, locatie D&A Research and Genetics ( Site 1103)

    RECRUITING

    Sneek, Provincie Friesland, 8601 ZR, Netherlands

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0132)

    RECRUITING

    Troy, Michigan, 48098, United States

  • Bravis Ziekenhuis, locatie Roosendaal ( Site 1102)

    RECRUITING

    Roosendaal, North Brabant, 4708 AE, Netherlands

  • Carient Heart & Vascular - Manassas ( Site 0165)

    RECRUITING

    Manassas, Virginia, 20109, United States

  • Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0154)

    RECRUITING

    Houston, Texas, 77030, United States

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0714)

    RECRUITING

    Berlin, 12203, Germany

  • Chase Medical Research, LLC ( Site 0163)

    RECRUITING

    Waterbury, Connecticut, 06708, United States

  • Clinical Research Trials of Florida ( Site 0101)

    RECRUITING

    Tampa, Florida, 33607, United States

  • Clinique des Maladies Lipidiques de Quebec ( Site 0201)

    RECRUITING

    Québec, Quebec, G1V 4W2, Canada

  • Conquest Research LLC ( Site 0140)

    RECRUITING

    Winter Park, Florida, 32789, United States

  • DM Clinical Research ( Site 0115)

    RECRUITING

    Tomball, Texas, 77375, United States

  • Dedicated Research Site FutureMeds ( Site 0719)

    RECRUITING

    Offenbach, Hesse, 63065, Germany

  • Flourish Research - Bowie ( Site 0106)

    RECRUITING

    Bowie, Maryland, 20715, United States

  • FutureMeds GmbH ( Site 0718)

    RECRUITING

    Berlin, 10629, Germany

  • HOCH Health Ostschweiz ( Site 1703)

    RECRUITING

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Headlands Research CTR Lincoln ( Site 0127)

    RECRUITING

    Lincoln, California, 95648, United States

  • Holston Medical Group ( Site 0117)

    RECRUITING

    Kingsport, Tennessee, 37660, United States

  • Hopitaux Universitaires (Geneve) ( Site 1704)

    RECRUITING

    Geneva, 1211, Switzerland

  • Inpatient Research Clinic ( Site 0110)

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Kato Clinic of Internal Medicine ( Site 2402)

    RECRUITING

    Katsushika-ku, Tokyo, 125-0054, Japan

  • Klinikum Konstanz ( Site 0723)

    RECRUITING

    Konstanz, Baden-Wurttemberg, 78464, Germany

  • Kumanomae Nishimura Naika Clinic ( Site 2407)

    RECRUITING

    Arakawa City, Tokyo, 116-0012, Japan

  • Laurelton Heart Specialist PC ( Site 0155)

    RECRUITING

    Rosedale, New York, 11422, United States

  • Luzerner Kantonsspital ( Site 1702)

    RECRUITING

    Lucerne, 6000, Switzerland

  • Martini Ziekenhuis ( Site 1108)

    RECRUITING

    Groningen, 9728 NT, Netherlands

  • Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 2400)

    RECRUITING

    Fukuoka, 810-0001, Japan

  • Medical Corporation Heishinkai OCROM Clinic ( Site 2403)

    RECRUITING

    Suita, Osaka, 565-0853, Japan

  • Medical Corporation Heishinkai ToCROM Clinic ( Site 2404)

    RECRUITING

    Shinjuku, Tokyo, 160-0008, Japan

  • Midori Clinic ( Site 2401)

    RECRUITING

    Nagasaki, 852-8034, Japan

  • Minamino Cardiovascular Hospital ( Site 2406)

    RECRUITING

    Hachiōji, Tokyo, 192-0918, Japan

  • Minneapolis Heart Institute - Minneapolis ( Site 0130)

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Montana Medical Research, Inc. ( Site 0156)

    RECRUITING

    Missoula, Montana, 59808, United States

  • National Heart Institute ( Site 0113)

    RECRUITING

    Beverly Hills, California, 90211-2285, United States

  • New Mexico Clinical Research & Osteoporosis Center ( Site 0119)

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • North York Diagnostic and Cardiac Centre ( Site 0203)

    RECRUITING

    North York, Ontario, M6B 3H7, Canada

  • Nuevas Tecnologías en D y E - Sevillaocío ( Site 1412)

    RECRUITING

    Seville, 41003, Spain

  • Rainier Clinical Research Center ( Site 0116)

    RECRUITING

    Renton, Washington, 98057, United States

  • Regionshospitalet Viborg ( Site 0507)

    RECRUITING

    Viborg, Central Jutland, 8800, Denmark

  • Remington-Davis, Inc. ( Site 0107)

    RECRUITING

    Columbus, Ohio, 43215, United States

  • Sanos Clinic - Nordjylland ( Site 0502)

    RECRUITING

    Gandrup, North Denmark, 9362, Denmark

  • Soffer Health Institute ( Site 0123)

    RECRUITING

    Hollywood, Florida, 33020, United States

  • Studienzentrum Brinkum - Torsten Drescher & Dr. Lars Pohlmeier ( Site 0712)

    RECRUITING

    Stuhr, Lower Saxony, 28816, Germany

  • Swing Nozaki Clinic ( Site 2405)

    RECRUITING

    Musashino, Tokyo, 180-0022, Japan

  • Velocity Clinical Research Rockville ( Site 0146)

    RECRUITING

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research, Durham ( Site 0145)

    RECRUITING

    Durham, North Carolina, 27701, United States

  • Vithas Hospital Sevilla ( Site 1401)

    RECRUITING

    Castilleja de la Cuesta, Sevilla, 41950, Spain

  • Westside Center for Clinical Research ( Site 0161)

    RECRUITING

    Jacksonville, Florida, 32205, United States

  • Ziekenhuis Gelderse Vallei ( Site 1106)

    RECRUITING

    Ede, Gelderland, 6716 RP, Netherlands

  • Ziekenhuis St. Jansdal ( Site 1113)

    RECRUITING

    Harderwijk, Gelderland, 3844 DG, Netherlands

  • zibp GmbH ( Site 0716)

    RECRUITING

    Berlin, 10439, Germany

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