Recruiting

Phase 2

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07614984

Conditions

Lipoprotein(a)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-7262

Enlicitide

Placebo for MK-7262

Placebo for enlicitide

Study Details

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)

Study ID

NCT07614984

Start date

Jun 30, 2026

Status verified date

Aug, 2026

Completion date

Oct 12, 2027

Anticipated

Primary completion date

Oct 12, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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

active comparator: enlicitide monotherapy

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

experimental: MK-7262 monotherapy

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

experimental: MK-7262 + enlicitide

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

Interventions

MK-7262

Oral Coated Tablet

Enlicitide

Oral Coated Tablet

Placebo for MK-7262

Oral Coated Tablet

Placebo for enlicitide

Oral Coated Tablet

Primary outcome measure

Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8 [ Time Frame: Baseline and Week 8 ]
Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 [ Time Frame: Baseline and Week 8 ]
Number of Participants who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 20 Weeks ]
Number of Participants Who Discontinue Study Intervention Due to an AE [ Time Frame: Up to approximately 12 Weeks ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@merck.com

Locations

Advanced Cardiovascular - Alexander City ( Site 0158)

Recruiting

Alexander City, Alabama, United States, 35010

Contacts

Study Coordinator

256-215-5323

AMR Clinical Mobile ( Site 0149)

Recruiting

Mobile, Alabama, United States, 36608

Contacts

Study Coordinator

251-414-1984

National Heart Institute ( Site 0113)

Recruiting

Beverly Hills, California, United States, 90211-2285

Contacts

Study Coordinator

310-289-5221

Headlands Research CTR Lincoln ( Site 0127)

Recruiting

Lincoln, California, United States, 95648

Contacts

Study Coordinator

916-434-8230

Chase Medical Research, LLC ( Site 0163)

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

Study Coordinator

203-419-4420

Soffer Health Institute ( Site 0123)

Recruiting

Hollywood, Florida, United States, 33020

Contacts

Study Coordinator

305-250-2106

Westside Center for Clinical Research ( Site 0161)

Recruiting

Jacksonville, Florida, United States, 32205

Contacts

Study Coordinator

904-693-1490

Inpatient Research Clinic ( Site 0110)

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Study Coordinator

786-502-4303

Clinical Research Trials of Florida ( Site 0101)

Recruiting

Tampa, Florida, United States, 33607

Contacts

Study Coordinator

813-873-8102

Conquest Research LLC ( Site 0140)

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Study Coordinator

407-916-0060

Flourish Research - Bowie ( Site 0106)

Recruiting

Bowie, Maryland, United States, 20715

Contacts

Study Coordinator

410-824-1341

Velocity Clinical Research Rockville ( Site 0146)

Recruiting

Rockville, Maryland, United States, 20854

Contacts

Study Coordinator

240-698-2800

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

Recruiting

Troy, Michigan, United States, 48098

Contacts

Study Coordinator

248-312-0025

Minneapolis Heart Institute - Minneapolis ( Site 0130)

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Study Coordinator

612-863-3833

Montana Medical Research, Inc. ( Site 0156)

Recruiting

Missoula, Montana, United States, 59808

Contacts

Study Coordinator

406-549-1124

New Mexico Clinical Research & Osteoporosis Center ( Site 0119)

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Study Coordinator

505-855-5505

Laurelton Heart Specialist PC ( Site 0155)

Recruiting

Rosedale, New York, United States, 11422

Contacts

Study Coordinator

718-949-9400

Velocity Clinical Research, Durham ( Site 0145)

Recruiting

Durham, North Carolina, United States, 27701

Contacts

Study Coordinator

919-503-4711

Remington-Davis, Inc. ( Site 0107)

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Study Coordinator

614-487-2560

Holston Medical Group ( Site 0117)

Recruiting

Kingsport, Tennessee, United States, 37660

Contacts

Study Coordinator

423-857-2789

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

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-798-5800

DM Clinical Research ( Site 0115)

Recruiting

Tomball, Texas, United States, 77375

Contacts

Study Coordinator

346-550-9559

Carient Heart & Vascular - Manassas ( Site 0165)

Recruiting

Manassas, Virginia, United States, 20109

Contacts

Study Coordinator

571-581-1771

Rainier Clinical Research Center ( Site 0116)

Recruiting

Renton, Washington, United States, 98057

Contacts

Study Coordinator

425-251-1720

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28.