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

NCT07216482 · tracked via the Priya Life Science UK tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 3

Started

2025-11-11

Last updated

2026-09-01

Condition(s) studied

Hyperlipidemia

Investigational drug(s) / intervention(s)

EnlicitideRosuvastatinPlacebo for EnlicitidePlacebo for Rosuvastatin

Enlicitide: Oral Tablet

Rosuvastatin: Oral Capsule

Placebo for Enlicitide: Oral Tablet

Placebo for Rosuvastatin: Oral Capsule

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

64 Years

Healthy volunteers

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.

Primary outcome measure(s)

Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo) — Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C between participants treated with enlicitide and rosuvastatin versus placebo.

Trial sites (87)

Facility	City	Region
Central Research Associates ( Site 0009)	Birmingham	Alabama
G&L Research ( Site 0024)	Foley	Alabama
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)	Phoenix	Arizona
Alliance for Multispecialty Research LLC ( Site 0049)	Tempe	Arizona
Chemidox Clinical Trials ( Site 0008)	Lancaster	California
Clinical Trials Research ( Site 0036)	Sacramento	California
Legacy Clinical Trials ( Site 0044)	Colorado Springs	Colorado
Alliance for Multispecialty Research, LLC ( Site 0040)	Fort Myers	Florida
Soffer Health Institute ( Site 0046)	Hollywood	Florida
East Coast Institute for Research ( Site 0041)	Lake City	Florida
Inpatient Research Clinic ( Site 0017)	Miami Lakes	Florida
Clinical Research Trials of Florida ( Site 0001)	Tampa	Florida
Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)	Winter Park	Florida
Trialmed ( Site 0026)	Chicago	Illinois
Great Lakes Clinical Trials - Ravenswood ( Site 0018)	Chicago	Illinois
Midwest Institute For Clinical Research ( Site 0033)	Indianapolis	Indiana
Alliance for Multispecialty Research, LLC ( Site 0048)	Newton	Kansas
Cotton O'Neil Clinical Research Center ( Site 0006)	Topeka	Kansas
L-MARC Research Center ( Site 0004)	Louisville	Kentucky
Jubilee Clinical Research ( Site 0031)	Las Vegas	Nevada
Cardiovascular Associates of the Delaware Valley ( Site 0035)	Elmer	New Jersey
New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)	Albuquerque	New Mexico
Alliance for Multispecialty Research, LLC - Norman ( Site 0043)	Norman	Oklahoma
Cardiology Consultants of Philadelphia Yardley ( Site 0016)	Yardley	Pennsylvania
Provecta Research Network LLC ( Site 0022)	Houston	Texas
Permian Research Foundation ( Site 0005)	Odessa	Texas
LinQ Research ( Site 0025)	Pearland	Texas
Clinical Trials of Texas, Inc. ( Site 0010)	San Antonio	Texas
Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)	San Antonio	Texas
LinQ Research - Tomball ( Site 0047)	Tomball	Texas
Conquest Research ( Site 0045)	Arlington	Virginia
Manassas Clinical Research Center ( Site 0002)	Manassas	Virginia
Health Research of Hampton Roads, Inc. ( Site 0013)	Newport News	Virginia
National Clinical Research, Inc ( Site 0028)	Richmond	Virginia
Rainier Clinical Research ( Site 0023)	Renton	Washington
CEMEDIC ( Site 0201)	CABA	Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)	Mar del Plata	Buenos Aires
CIPREC-CIPREC Sede Arenales ( Site 0200)	Buenos Aires	Buenos Aires F.D.
Fundacion Estudios Clinicos ( Site 0203)	Rosario	Santa Fe Province
Instituto de Investigaciones Clinicas Rosario ( Site 0204)	Rosario	Santa Fe Province

+ 47 more sites — see the full list on the official registry below.

On this site

📄 Crestor (rosuvastatin) drug profile →

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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 NCT07216482 on ClinicalTrials.gov ↗ ← All trials in the UK