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

NCT07614984 | Recruiting Phase 2 FDA Drug

• 6 other identifiers: 7262-004MK-7262-004U1111-1333-18322025-525102-38-00jRCT20212600242025
• Study Type: interventional
• Target: 750
• Locations: 9 countries
• Sites: 70

Brief 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

Conditions

Lipoprotein(a)

Outcome Measures

Primary Outcomes (4)

• Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8

  Blood samples will be collected at baseline and at Week 8 to assess the mean percent change from baseline in Lp(a).

  Baseline and Week 8

• Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8

  Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C.

  Baseline and Week 8

• Number of Participants who Experience One or More Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  Up to approximately 20 Weeks

• Number of Participants Who Discontinue Study Intervention Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

  Up to approximately 12 Weeks

Secondary Outcomes (8)

• Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo)

  Baseline and Week 8

• Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo)

  Baseline and Week 8

• Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy)

  Baseline and Week 8

• Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy)

  Baseline and Week 8

• Percentage of Participants with Lp(a) <125 nmol/L at Week 8

  Week 8

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.

Drug: Placebo for MK-7262; Drug: Placebo for enlicitide

enlicitide monotherapy

ACTIVE COMPARATOR

Participants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment.

Drug: Enlicitide; Drug: Placebo for MK-7262

MK-7262 monotherapy

EXPERIMENTAL

Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment.

Drug: MK-7262; Drug: Placebo for enlicitide

MK-7262 + enlicitide

EXPERIMENTAL

Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment.

Drug: MK-7262; Drug: Enlicitide

Interventions

Enlicitide DRUG

Oral Coated Tablet

Also known as: MK-0616, enlicitide decanoate

MK-7262 + enlicitide; enlicitide monotherapy

Placebo for MK-7262 DRUG

Oral Coated Tablet

Placebo; enlicitide monotherapy

MK-7262 DRUG

Oral Coated Tablet

Also known as: HRS-5346

MK-7262 + enlicitide; MK-7262 monotherapy

Placebo for enlicitide DRUG

Oral Coated Tablet

MK-7262 monotherapy; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (70)

Advanced Cardiovascular - Alexander City ( Site 0158)

Alexander City, Alabama, 35010, United States

RECRUITING

AMR Clinical Mobile ( Site 0149)

Mobile, Alabama, 36608, United States

RECRUITING

National Heart Institute ( Site 0113)

Beverly Hills, California, 90211-2285, United States

RECRUITING

Headlands Research CTR Lincoln ( Site 0127)

Lincoln, California, 95648, United States

RECRUITING

Chase Medical Research, LLC ( Site 0163)

Waterbury, Connecticut, 06708, United States

RECRUITING

Soffer Health Institute ( Site 0123)

Hollywood, Florida, 33020, United States

RECRUITING

Westside Center for Clinical Research ( Site 0161)

Jacksonville, Florida, 32205, United States

RECRUITING

Inpatient Research Clinic ( Site 0110)

Miami Lakes, Florida, 33014, United States

RECRUITING

Clinical Research Trials of Florida ( Site 0101)

Tampa, Florida, 33607, United States

RECRUITING

Conquest Research LLC ( Site 0140)

Winter Park, Florida, 32789, United States

RECRUITING

Flourish Research - Bowie ( Site 0106)

Bowie, Maryland, 20715, United States

RECRUITING

Velocity Clinical Research Rockville ( Site 0146)

Rockville, Maryland, 20854, United States

RECRUITING

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

Troy, Michigan, 48098, United States

RECRUITING

Minneapolis Heart Institute - Minneapolis ( Site 0130)

Minneapolis, Minnesota, 55407, United States

RECRUITING

Montana Medical Research, Inc. ( Site 0156)

Missoula, Montana, 59808, United States

RECRUITING

New Mexico Clinical Research & Osteoporosis Center ( Site 0119)

Albuquerque, New Mexico, 87106, United States

RECRUITING

Laurelton Heart Specialist PC ( Site 0155)

Rosedale, New York, 11422, United States

RECRUITING

Velocity Clinical Research, Durham ( Site 0145)

Durham, North Carolina, 27701, United States

RECRUITING

Remington-Davis, Inc. ( Site 0107)

Columbus, Ohio, 43215, United States

RECRUITING

Holston Medical Group ( Site 0117)

Kingsport, Tennessee, 37660, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

DM Clinical Research ( Site 0115)

Tomball, Texas, 77375, United States

RECRUITING

Carient Heart & Vascular - Manassas ( Site 0165)

Manassas, Virginia, 20109, United States

RECRUITING

Rainier Clinical Research Center ( Site 0116)

Renton, Washington, 98057, United States

RECRUITING

North York Diagnostic and Cardiac Centre ( Site 0203)

North York, Ontario, M6B 3H7, Canada

RECRUITING

Clinique des Maladies Lipidiques de Quebec ( Site 0201)

Québec, Quebec, G1V 4W2, Canada

RECRUITING

Salud SURA Industriales ( Site 0405)

Medellín, Antioquia, 05001, Colombia

RECRUITING

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

Barranquilla, Atlántico, 80020, Colombia

RECRUITING

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

Bogota, Cundinamarca, 110221, Colombia

RECRUITING

IMAT S.A.S ( Site 0400)

Montería, Departamento de Córdoba, 23001, Colombia

RECRUITING

Regionshospitalet Viborg ( Site 0507)

Viborg, Central Jutland, 8800, Denmark

RECRUITING

Sanos Clinic - Nordjylland ( Site 0502)

Gandrup, North Denmark, 9362, Denmark

RECRUITING

Esbjerg sygehus, Syddansk Universitetshospital ( Site 0505)

Esbjerg, Region Syddanmark, 6700, Denmark

RECRUITING

OUH Svendborg Sygehus ( Site 0500)

Svendborg, Region Syddanmark, 5700, Denmark

RECRUITING

Klinikum Konstanz ( Site 0723)

Konstanz, Baden-Wurttemberg, 78464, Germany

RECRUITING

Deutsches Herzzentrum Muenchen ( Site 0717)

Munich, Bavaria, 80636, Germany

RECRUITING

Ambulantes Herzzentrum Kassel ( Site 0721)

Kassel, Hesse, 34121, Germany

RECRUITING

Dedicated Research Site FutureMeds ( Site 0719)

Offenbach, Hesse, 63065, Germany

RECRUITING

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

Stuhr, Lower Saxony, 28816, Germany

RECRUITING

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

Dresden, Saxony, 01307, Germany

RECRUITING

zibp GmbH ( Site 0716)

Berlin, 10439, Germany

RECRUITING

FutureMeds GmbH ( Site 0718)

Berlin, 10629, Germany

RECRUITING

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0714)

Berlin, 12203, Germany

RECRUITING

Medical Corporation Heishinkai OCROM Clinic ( Site 2403)

Suita, Osaka, 565-0853, Japan

RECRUITING

Kumanomae Nishimura Naika Clinic ( Site 2407)

Arakawa City, Tokyo, 116-0012, Japan

RECRUITING

Minamino Cardiovascular Hospital ( Site 2406)

Hachiōji, Tokyo, 192-0918, Japan

RECRUITING

Kato Clinic of Internal Medicine ( Site 2402)

Katsushika-ku, Tokyo, 125-0054, Japan

RECRUITING

Swing Nozaki Clinic ( Site 2405)

Musashino, Tokyo, 180-0022, Japan

RECRUITING

Medical Corporation Heishinkai ToCROM Clinic ( Site 2404)

Shinjuku, Tokyo, 160-0008, Japan

RECRUITING

Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 2400)

Fukuoka, 810-0001, Japan

RECRUITING

Midori Clinic ( Site 2401)

Nagasaki, 852-8034, Japan

RECRUITING

National Hospital Organization Osaka National Hospital ( Site 2408)

Osaka, 540-0006, Japan

RECRUITING

Ziekenhuis Gelderse Vallei ( Site 1106)

Ede, Gelderland, 6716 RP, Netherlands

RECRUITING

Ziekenhuis St. Jansdal ( Site 1113)

Harderwijk, Gelderland, 3844 DG, Netherlands

RECRUITING

Bravis Ziekenhuis, locatie Roosendaal ( Site 1102)

Roosendaal, North Brabant, 4708 AE, Netherlands

RECRUITING

Noordwest Ziekenhuisgroep ( Site 1110)

Alkmaar, North Holland, 1815 JD, Netherlands

RECRUITING

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

Sneek, Provincie Friesland, 8601 ZR, Netherlands

RECRUITING

Albert Schweitzer Ziekenhuis, locatie Dordwijk ( Site 1101)

Dordrecht, South Holland, 3318 AT, Netherlands

RECRUITING

Martini Ziekenhuis ( Site 1108)

Groningen, 9728 NT, Netherlands

RECRUITING

Hospital San Rafael - La Coruña ( Site 1402)

A Coruña, La Coruna, 15006, Spain

RECRUITING

Vithas Hospital Sevilla ( Site 1401)

Castilleja de la Cuesta, Sevilla, 41950, Spain

RECRUITING

Hospital Universitari Vall d Hebron ( Site 1403)

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona ( Site 1419)

Barcelona, 08036, Spain

RECRUITING

Hospital Viamed Santa Elena ( Site 1422)

Madrid, 28003, Spain

RECRUITING

Hospital Universitario La Paz ( Site 1405)

Madrid, 28046, Spain

RECRUITING

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

Seville, 41003, Spain

RECRUITING

University Hospital Basel ( Site 1701)

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

HOCH Health Ostschweiz ( Site 1703)

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

RECRUITING

Hopitaux Universitaires (Geneve) ( Site 1704)

Geneva, 1211, Switzerland

RECRUITING

Luzerner Kantonsspital ( Site 1702)

Lucerne, 6000, Switzerland

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

MK-0616

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): October 12, 2027
• Study Completion (Estimated): October 12, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (24); CH (4); JP (9); NL (7); ES (7); CA (2); DK (4); DE (9); CO (4)