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NCT07614984PHASE2Recruiting

A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)

Merck Sharp & Dohme LLC

Start Date

6/30/2026

Completion Date

10/12/2027

Summary

Researchers designed a trial medicine called MK-7262 to lower levels of Lp(a) in the blood. Researchers want to learn about giving MK-7262 with another trial medicine called enlicitide (also known as MK-0616 or enlicitide decanoate). Enlicitide is in a group of medicines that lower the amount of low-density lipoprotein cholesterol (LDL-C). The goals of this trial are to evaluate: * if MK-7262 and enlicitide taken together work better than placebo at lowering Lp(a) and LDL-C levels in the blood * if MK-7262 alone works better than placebo at lowering Lp(a) levels in the blood * the safety and tolerability of taking MK-7262 and enlicitide alone and together

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

MK-7262

DRUG

Enlicitide

DRUG

Placebo for MK-7262

DRUG

Placebo for enlicitide

Interested in This Trial?

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Conditions

Lipoprotein(a)

Locations

Advanced Cardiovascular - Alexander City ( Site 0158)

Alexander City, Alabama 35010

United States

AMR Clinical Mobile ( Site 0149)

Mobile, Alabama 36608

United States

National Heart Institute ( Site 0113)

Beverly Hills, California 90211-2285

United States

Headlands Research CTR Lincoln ( Site 0127)

Lincoln, California 95648

United States

Chase Medical Research, LLC ( Site 0163)

Waterbury, Connecticut 06708

United States

Soffer Health Institute ( Site 0123)

Hollywood, Florida 33020

United States

Westside Center for Clinical Research ( Site 0161)

Jacksonville, Florida 32205

United States

Inpatient Research Clinic ( Site 0110)

Miami Lakes, Florida 33014

United States

Clinical Research Trials of Florida ( Site 0101)

Tampa, Florida 33607

United States

Conquest Research LLC ( Site 0140)

Winter Park, Florida 32789

United States

Flourish Research - Bowie ( Site 0106)

Bowie, Maryland 20715

United States

Velocity Clinical Research Rockville ( Site 0146)

Rockville, Maryland 20854

United States

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

Troy, Michigan 48098

United States

Minneapolis Heart Institute - Minneapolis ( Site 0130)

Minneapolis, Minnesota 55407

United States

Montana Medical Research, Inc. ( Site 0156)

Missoula, Montana 59808

United States

New Mexico Clinical Research & Osteoporosis Center ( Site 0119)

Albuquerque, New Mexico 87106

United States

Laurelton Heart Specialist PC ( Site 0155)

Rosedale, New York 11422

United States

Velocity Clinical Research, Durham ( Site 0145)

Durham, North Carolina 27701

United States

Remington-Davis, Inc. ( Site 0107)

Columbus, Ohio 43215

United States

Holston Medical Group ( Site 0117)

Kingsport, Tennessee 37660

United States

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

Houston, Texas 77030

United States

DM Clinical Research ( Site 0115)

Tomball, Texas 77375

United States

Carient Heart & Vascular - Manassas ( Site 0165)

Manassas, Virginia 20109

United States

Rainier Clinical Research Center ( Site 0116)

Renton, Washington 98057

United States

North York Diagnostic and Cardiac Centre ( Site 0203)

North York, Ontario M6B 3H7

Canada

Ecogene-21 ( Site 0202)

Chicoutimi, Quebec G7H 7K9

Canada

Clinique des Maladies Lipidiques de Quebec ( Site 0201)

Québec, Quebec G1V 4W2

Canada

Diex Recherche Trois-Rivieres ( Site 0204)

Trois-Rivières, Quebec G9A 4P3

Canada

Salud SURA Industriales ( Site 0405)

Medellín, Antioquia 05001

Colombia

Clinica de la Costa S.A.S ( Site 0404)

Barranquilla, Atlántico 80020

Colombia

Solano & Terront Servicios Medicos - UNIENDO SAS ( Site 0402)

Bogota, Cundinamarca 110221

Colombia

IMAT S.A.S ( Site 0400)

Montería, Departamento de Córdoba 23001

Colombia

Regionshospitalet Viborg ( Site 0507)

Viborg, Central Jutland 8800

Denmark

Sanos Clinic - Nordjylland ( Site 0502)

Gandrup, North Denmark 9362

Denmark

Esbjerg sygehus, Syddansk Universitetshospital ( Site 0505)

Esbjerg, Region Syddanmark 6700

Denmark

OUH Svendborg Sygehus ( Site 0500)

Svendborg, Region Syddanmark 5700

Denmark

Klinikum Konstanz ( Site 0723)

Konstanz, Baden-Wurttemberg 78464

Germany

Deutsches Herzzentrum Muenchen ( Site 0717)

Munich, Bavaria 80636

Germany

Ambulantes Herzzentrum Kassel ( Site 0721)

Kassel, Hesse 34121

Germany

Dedicated Research Site FutureMeds ( Site 0719)

Offenbach, Hesse 63065

Germany

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

Stuhr, Lower Saxony 28816

Germany

Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden' ( Site 0713)

Dresden, Saxony 01307

Germany

zibp GmbH ( Site 0716)

Berlin, 10439

Germany

FutureMeds GmbH ( Site 0718)

Berlin, 10629

Germany

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0714)

Berlin, 12203

Germany

Medical Corporation Heishinkai OCROM Clinic ( Site 2403)

Suita, Osaka 565-0853

Japan

Kumanomae Nishimura Naika Clinic ( Site 2407)

Arakawa City, Tokyo 116-0012

Japan

Minamino Cardiovascular Hospital ( Site 2406)

Hachiōji, Tokyo 192-0918

Japan

Kato Clinic of Internal Medicine ( Site 2402)

Katsushika-ku, Tokyo 125-0054

Japan

Swing Nozaki Clinic ( Site 2405)

Musashino, Tokyo 180-0022

Japan

Medical Corporation Heishinkai ToCROM Clinic ( Site 2404)

Shinjuku, Tokyo 160-0008

Japan

Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 2400)

Fukuoka, 810-0001

Japan

Midori Clinic ( Site 2401)

Nagasaki, 852-8034

Japan

National Hospital Organization Osaka National Hospital ( Site 2408)

Osaka, 540-0006

Japan

Ziekenhuis Gelderse Vallei ( Site 1106)

Ede, Gelderland 6716 RP

Netherlands

Ziekenhuis St. Jansdal ( Site 1113)

Harderwijk, Gelderland 3844 DG

Netherlands

Bravis Ziekenhuis, locatie Roosendaal ( Site 1102)

Roosendaal, North Brabant 4708 AE

Netherlands

Noordwest Ziekenhuisgroep ( Site 1110)

Alkmaar, North Holland 1815 JD

Netherlands

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

Sneek, Provincie Friesland 8601 ZR

Netherlands

Albert Schweitzer Ziekenhuis, locatie Dordwijk ( Site 1101)

Dordrecht, South Holland 3318 AT

Netherlands

Martini Ziekenhuis ( Site 1108)

Groningen, 9728 NT

Netherlands

Hospital San Rafael - La Coruña ( Site 1402)

A Coruña, La Coruna 15006

Spain

Vithas Hospital Sevilla ( Site 1401)

Castilleja de la Cuesta, Sevilla 41950

Spain

Hospital Universitari Vall d Hebron ( Site 1403)

Barcelona, 08035

Spain

Hospital Clinic de Barcelona ( Site 1419)

Barcelona, 08036

Spain

Hospital Viamed Santa Elena ( Site 1422)

Madrid, 28003

Spain

Hospital Universitario La Paz ( Site 1405)

Madrid, 28046

Spain

Hospital Universitario Virgen de la Arrixaca ( Site 1406)

Murcia, 30120

Spain

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

Seville, 41003

Spain

University Hospital Basel ( Site 1701)

Basel, Canton of Basel-City 4031

Switzerland

HOCH Health Ostschweiz ( Site 1703)

Sankt Gallen, Canton of St. Gallen 9007

Switzerland

Istituto Cardiocentro Ticino - Ente Ospedaliero Cantonale ( Site 1705)

Lugano, Canton Ticino 6900

Switzerland

Hopitaux Universitaires (Geneve) ( Site 1704)

Geneva, 1211

Switzerland

Luzerner Kantonsspital ( Site 1702)

Lucerne, 6000

Switzerland