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

NCT07614984 · tracked via the Priya Life Science USA tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 2

Started

2026-06-30

Last updated

2026-09-15

Condition(s) studied

Lipoprotein(a)

Investigational drug(s) / intervention(s)

MK-7262EnlicitidePlacebo for MK-7262Placebo for enlicitide

MK-7262: Oral Coated Tablet

Enlicitide: Oral Coated Tablet

Placebo for MK-7262: Oral Coated Tablet

Placebo for enlicitide: Oral Coated Tablet

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8 — Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change from baseline in Lp(a).
Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 — Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C.
Number of Participants who Experience One or More Adverse Events (AEs) — Up to approximately 20 Weeks
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.
Number of Participants Who Discontinue Study Intervention Due to an AE — Up to approximately 12 Weeks
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.

Trial sites (54)

Facility	City	Region	Status
Advanced Cardiovascular - Alexander City ( Site 0158)	Alexander City	Alabama	Recruiting
AMR Clinical Mobile ( Site 0149)	Mobile	Alabama	Recruiting
National Heart Institute ( Site 0113)	Beverly Hills	California	Recruiting
Headlands Research CTR Lincoln ( Site 0127)	Lincoln	California	Recruiting
Chase Medical Research, LLC ( Site 0163)	Waterbury	Connecticut	Recruiting
Soffer Health Institute ( Site 0123)	Hollywood	Florida	Recruiting
Westside Center for Clinical Research ( Site 0161)	Jacksonville	Florida	Recruiting
Inpatient Research Clinic ( Site 0110)	Miami Lakes	Florida	Recruiting
Clinical Research Trials of Florida ( Site 0101)	Tampa	Florida	Recruiting
Conquest Research LLC ( Site 0140)	Winter Park	Florida	Recruiting
Flourish Research - Bowie ( Site 0106)	Bowie	Maryland	Recruiting
Velocity Clinical Research Rockville ( Site 0146)	Rockville	Maryland	Recruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0132)	Troy	Michigan	Recruiting
Minneapolis Heart Institute - Minneapolis ( Site 0130)	Minneapolis	Minnesota	Recruiting
Montana Medical Research, Inc. ( Site 0156)	Missoula	Montana	Recruiting
New Mexico Clinical Research & Osteoporosis Center ( Site 0119)	Albuquerque	New Mexico	Recruiting
Laurelton Heart Specialist PC ( Site 0155)	Rosedale	New York	Recruiting
Velocity Clinical Research, Durham ( Site 0145)	Durham	North Carolina	Recruiting
Remington-Davis, Inc. ( Site 0107)	Columbus	Ohio	Recruiting
Holston Medical Group ( Site 0117)	Kingsport	Tennessee	Recruiting
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0154)	Houston	Texas	Recruiting
DM Clinical Research ( Site 0115)	Tomball	Texas	Recruiting
Carient Heart & Vascular - Manassas ( Site 0165)	Manassas	Virginia	Recruiting
Rainier Clinical Research Center ( Site 0116)	Renton	Washington	Recruiting
North York Diagnostic and Cardiac Centre ( Site 0203)	North York	Ontario	Recruiting
Clinique des Maladies Lipidiques de Quebec ( Site 0201)	Québec	Quebec	Recruiting
Regionshospitalet Viborg ( Site 0507)	Viborg	Central Jutland	Recruiting
Sanos Clinic - Nordjylland ( Site 0502)	Gandrup	North Denmark	Recruiting
Klinikum Konstanz ( Site 0723)	Konstanz	Baden-Wurttemberg	Recruiting
Ambulantes Herzzentrum Kassel ( Site 0721)	Kassel	Hesse	Recruiting
Dedicated Research Site FutureMeds ( Site 0719)	Offenbach	Hesse	Recruiting
Studienzentrum Brinkum - Torsten Drescher & Dr. Lars Pohlmeier ( Site 0712)	Stuhr	Lower Saxony	Recruiting
zibp GmbH ( Site 0716)	Berlin	Germany	Recruiting
FutureMeds GmbH ( Site 0718)	Berlin	Germany	Recruiting
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0714)	Berlin	Germany	Recruiting
Medical Corporation Heishinkai OCROM Clinic ( Site 2403)	Suita	Osaka	Recruiting
Kumanomae Nishimura Naika Clinic ( Site 2407)	Arakawa City	Tokyo	Recruiting
Minamino Cardiovascular Hospital ( Site 2406)	Hachiōji	Tokyo	Recruiting
Kato Clinic of Internal Medicine ( Site 2402)	Katsushika-ku	Tokyo	Recruiting
Swing Nozaki Clinic ( Site 2405)	Musashino	Tokyo	Recruiting

+ 14 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07614984 on ClinicalTrials.gov ↗ ← All trials in the USA