NCT07216482

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 975 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Enlicitide	Oral Tablet
DRUG	Rosuvastatin	Oral Capsule
DRUG	Placebo for Enlicitide	Oral Tablet
DRUG	Placebo for Rosuvastatin	Oral Capsule

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-12-02
• Completion: 2027-03-01
• First posted: 2025-10-14
• Last updated: 2026-04-13

Locations

88 sites across 11 countries: United States, Argentina, Australia, Brazil, Canada, Hungary, Israel, New Zealand, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study