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A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)

NCT ID: NCT07216482

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

975 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-11

Study Completion Date

2027-03-01

Brief Summary

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Researchers designed a study medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C). In this study, researchers want to learn about giving enlicitide with another medicine called rosuvastatin. Rosuvastatin is a standard (usual) treatment to lower LDL-C.

The goal of this study is to learn if enlicitide given with rosuvastatin works better than placebo on lowering LDL-C in a person's blood. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine.

Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Enlicitide

Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral Tablet

Placebo for Rosuvastatin

Intervention Type DRUG

Oral Capsule

Enlicitide + Rosuvastatin

Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral Tablet

Rosuvastatin

Intervention Type DRUG

Oral Capsule

Rosuvastatin

Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

Oral Capsule

Placebo for Enlicitide

Intervention Type DRUG

Oral Tablet

Placebo

Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo for Enlicitide

Intervention Type DRUG

Oral Tablet

Placebo for Rosuvastatin

Intervention Type DRUG

Oral Capsule

Interventions

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Enlicitide

Oral Tablet

Intervention Type DRUG

Rosuvastatin

Oral Capsule

Intervention Type DRUG

Placebo for Enlicitide

Oral Tablet

Intervention Type DRUG

Placebo for Rosuvastatin

Oral Capsule

Intervention Type DRUG

Other Intervention Names

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MK-0616 Enlicitide decanoate

Eligibility Criteria

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Inclusion Criteria

-Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.

Exclusion Criteria

* Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.
* Had a heart failure hospitalization within 3 months before Screening.
* Is unwilling to take a statin, and/or has a history of statin-associated muscle symptoms or other statin-related AEs to any statin and dose, and/or is known to be intolerant to 1 or more statins.
* Has a history of any of the following conditions: (1) Myopathy, myositis, rhabdomyolysis, or unexplained muscle pain; (2) Muscular or neuromuscular disease; (3) Neuropathy, fibromyalgia, or chronic pain; or (4) Has a personal or family history of hereditary muscular disorders.
* Has active or chronic hepatobiliary or hepatic disease.
* Has known human immunodeficiency virus (HIV) infection.
* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Screening or plans to initiate an LDL-C apheresis program.
* Has received any medication that may interact with rosuvastatin within 5 half-lives prior to Screening or is planning to initiate such treatment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Central Research Associates ( Site 0009)

Birmingham, Alabama, United States

Site Status RECRUITING

G&L Research ( Site 0024)

Foley, Alabama, United States

Site Status RECRUITING

Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)

Phoenix, Arizona, United States

Site Status RECRUITING

Alliance for Multispecialty Research LLC ( Site 0049)

Tempe, Arizona, United States

Site Status RECRUITING

Chemidox Clinical Trials ( Site 0008)

Lancaster, California, United States

Site Status RECRUITING

Clinical Trials Research ( Site 0036)

Sacramento, California, United States

Site Status RECRUITING

Legacy Clinical Trials ( Site 0044)

Colorado Springs, Colorado, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC ( Site 0040)

Fort Myers, Florida, United States

Site Status RECRUITING

Soffer Health Institute ( Site 0046)

Hollywood, Florida, United States

Site Status RECRUITING

East Coast Institute for Research ( Site 0041)

Lake City, Florida, United States

Site Status RECRUITING

Inpatient Research Clinic ( Site 0017)

Miami Lakes, Florida, United States

Site Status RECRUITING

Clinical Research Trials of Florida ( Site 0001)

Tampa, Florida, United States

Site Status RECRUITING

Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)

Winter Park, Florida, United States

Site Status RECRUITING

Trialmed ( Site 0026)

Chicago, Illinois, United States

Site Status RECRUITING

Great Lakes Clinical Trials - Ravenswood ( Site 0018)

Chicago, Illinois, United States

Site Status RECRUITING

Midwest Institute For Clinical Research ( Site 0033)

Indianapolis, Indiana, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC ( Site 0048)

Newton, Kansas, United States

Site Status RECRUITING

Cotton O'Neil Clinical Research Center ( Site 0006)

Topeka, Kansas, United States

Site Status RECRUITING

L-MARC Research Center ( Site 0004)

Louisville, Kentucky, United States

Site Status RECRUITING

Jubilee Clinical Research ( Site 0031)

Las Vegas, Nevada, United States

Site Status RECRUITING

Cardiovascular Associates of the Delaware Valley ( Site 0035)

Elmer, New Jersey, United States

Site Status RECRUITING

New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)

Albuquerque, New Mexico, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC - Norman ( Site 0043)

Norman, Oklahoma, United States

Site Status RECRUITING

Cardiology Consultants of Philadelphia Yardley ( Site 0016)

Yardley, Pennsylvania, United States

Site Status RECRUITING

Provecta Research Network LLC ( Site 0022)

Houston, Texas, United States

Site Status RECRUITING

Permian Research Foundation ( Site 0005)

Odessa, Texas, United States

Site Status RECRUITING

LinQ Research ( Site 0025)

Pearland, Texas, United States

Site Status RECRUITING

Clinical Trials of Texas, Inc. ( Site 0010)

San Antonio, Texas, United States

Site Status RECRUITING

Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)

San Antonio, Texas, United States

Site Status RECRUITING

LinQ Research - Tomball ( Site 0047)

Tomball, Texas, United States

Site Status RECRUITING

Conquest Research ( Site 0045)

Arlington, Virginia, United States

Site Status RECRUITING

Manassas Clinical Research Center ( Site 0002)

Manassas, Virginia, United States

Site Status RECRUITING

Health Research of Hampton Roads, Inc. ( Site 0013)

Newport News, Virginia, United States

Site Status RECRUITING

National Clinical Research, Inc ( Site 0028)

Richmond, Virginia, United States

Site Status RECRUITING

Rainier Clinical Research ( Site 0023)

Renton, Washington, United States

Site Status RECRUITING

Australian Clinical Research Network ( Site 0900)

Maroubra, New South Wales, Australia

Site Status RECRUITING

Momentum Darlinghurst ( Site 0906)

Sydney, New South Wales, Australia

Site Status RECRUITING

Momentum Clinical Research Taringa ( Site 0907)

Taringa, Queensland, Australia

Site Status RECRUITING

Fusion Clinical Research ( Site 0901)

Norwood, South Australia, Australia

Site Status RECRUITING

Emeritus Research ( Site 0904)

Camberwell, Victoria, Australia

Site Status RECRUITING

Baker - HeartWest ( Site 0902)

Hoppers Crossing, Victoria, Australia

Site Status RECRUITING

Milestone Research Inc. ( Site 0111)

London, Ontario, Canada

Site Status RECRUITING

North York Diagnostic and Cardiac Centre ( Site 0110)

North York, Ontario, Canada

Site Status RECRUITING

Borbánya Praxis ( Site 1103)

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Site Status RECRUITING

Barzilai Medical Center ( Site 0504)

Ashkelon, , Israel

Site Status RECRUITING

Rambam Health Care Campus ( Site 0500)

Haifa, , Israel

Site Status RECRUITING

Meir Medical Center. ( Site 0501)

Kfar Saba, , Israel

Site Status RECRUITING

EAP Sardenya ( Site 0601)

Barcelona, , Spain

Site Status RECRUITING

Velocity Clinical Research Romford ( Site 0803)

Bristol, Bristol, City of, United Kingdom

Site Status RECRUITING

West Walk Surgery ( Site 0801)

Yate, Gloucestershire, United Kingdom

Site Status RECRUITING

Velocity Clinical Research Havering ( Site 0804)

London, Havering, United Kingdom

Site Status RECRUITING

William Harvey Heart Centre ( Site 0800)

London, London, City of, United Kingdom

Site Status RECRUITING

Lakeside Surgery ( Site 0802)

Corby, Northamptonshire, United Kingdom

Site Status RECRUITING

Countries

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United States Australia Canada Hungary Israel Spain United Kingdom

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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U1111-1319-9502

Identifier Type: REGISTRY

Identifier Source: secondary_id

2025-521495-54-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-0616-037

Identifier Type: OTHER

Identifier Source: secondary_id

0616-037

Identifier Type: -

Identifier Source: org_study_id