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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT07216482

Run by

Merck Sharp & Dohme LLC

People needed

975

Starts

2025-11-11

Expected to finish

2026-11-05

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• G&L Research ( Site 0024) — Foley, Alabama, United States
• Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030) — Phoenix, Arizona, United States
• Alliance for Multispecialty Research LLC ( Site 0049) — Tempe, Arizona, United States
• Chemidox Clinical Trials ( Site 0008) — Lancaster, California, United States
• Clinical Trials Research ( Site 0036) — Sacramento, California, United States
• Legacy Clinical Trials ( Site 0044) — Colorado Springs, Colorado, United States
• Alliance for Multispecialty Research, LLC ( Site 0040) — Fort Myers, Florida, United States
• Soffer Health Institute ( Site 0046) — Hollywood, Florida, United States
• East Coast Institute for Research ( Site 0041) — Lake City, Florida, United States
• Inpatient Research Clinic ( Site 0017) — Miami Lakes, Florida, United States
• Clinical Research Trials of Florida ( Site 0001) — Tampa, Florida, United States
• Clinical Site Partners LLC, dba CSP Orlando ( Site 0014) — Winter Park, Florida, United States
• Trialmed ( Site 0026) — Chicago, Illinois, United States
• Great Lakes Clinical Trials - Ravenswood ( Site 0018) — Chicago, Illinois, United States
• Midwest Institute For Clinical Research ( Site 0033) — Indianapolis, Indiana, United States
• Alliance for Multispecialty Research, LLC ( Site 0048) — Newton, Kansas, United States
• Cotton O'Neil Clinical Research Center ( Site 0006) — Topeka, Kansas, United States
• Monroe Biomedical Research ( Site 0004) — Louisville, Kentucky, United States
• Jubilee Clinical Research ( Site 0031) — Las Vegas, Nevada, United States
• Cardiovascular Associates of the Delaware Valley ( Site 0035) — Elmer, New Jersey, United States
• New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027) — Albuquerque, New Mexico, United States
• Alliance for Multispecialty Research, LLC - Norman ( Site 0043) — Norman, Oklahoma, United States
• Cardiology Consultants of Philadelphia Yardley ( Site 0016) — Yardley, Pennsylvania, United States
• Provecta Research Network LLC ( Site 0022) — Houston, Texas, United States
• Central Research Associates ( Site 0009) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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