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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Hyperlipidemia

Treatments: Drug: Placebo for Rosuvastatin; Drug: Enlicitide; Drug: Placebo for Enlicitide; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07216482

2025-521495-54-00 (Registry Identifier)

0616-037

MK-0616-037 (Other Identifier)

U1111-1319-9502 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 975 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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975 participants in 4 patient groups, including a placebo group

Enlicitide

Experimental group

Description:

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

Treatment:

Drug: Enlicitide

Drug: Placebo for Rosuvastatin

Enlicitide + Rosuvastatin

Experimental group

Description:

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

Treatment:

Drug: Rosuvastatin

Drug: Enlicitide

Rosuvastatin

Active Comparator group

Description:

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

Treatment:

Drug: Rosuvastatin

Drug: Placebo for Enlicitide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for Enlicitide

Drug: Placebo for Rosuvastatin