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

Conditions

• Hyperlipidemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• Enlicitide — DRUG
  Oral Tablet
• Rosuvastatin — DRUG
  Oral Capsule
• Placebo for Enlicitide — DRUG
  Oral Tablet
• Placebo for Rosuvastatin — DRUG
  Oral Capsule

Study Details

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 Dates

First listed

Oct 14, 2025

Start date

Nov 11, 2025

Status verified

Jun 2026

Primary completion

Dec 2, 2026

Completion

Mar 1, 2027

Study Design

Enrollment

975 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: Enlicitide
  Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
• Experimental: Enlicitide + Rosuvastatin
  Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
• Active Comparator: Rosuvastatin
  Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
• Placebo Comparator: Placebo
  Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.

Primary Outcome Measure

Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo) [ Time Frame: Baseline and Week 8 ]

Locations (35)

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