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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

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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

Clinical Trials Research ( Site 0127)

Lincoln, California 95648

United States

Chase Medical Research, LLC ( Site 0163)

Waterbury, Connecticut 06708

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

New Mexico Clinical Research & Osteoporosis Center ( Site 0119)

Albuquerque, New Mexico 87106

United States

Remington-Davis, Inc. ( Site 0107)

Columbus, Ohio 43215

United States

Holston Medical Group ( Site 0117)

Kingsport, Tennessee 37660

United States

Carient Heart & Vascular - Manassas ( Site 0165)

Manassas, Virginia 20109

United States