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

NCT07216482 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 975

Last updated 2026-05-18

No results posted yet for this 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.

Conditions

Interventions

DRUG

Enlicitide

Oral Tablet

DRUG

Rosuvastatin

Oral Capsule

DRUG

Placebo for Enlicitide

Oral Tablet

DRUG

Placebo for Rosuvastatin

Oral Capsule

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2026-12-02
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Hungary
  • Israel
  • New Zealand
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07216482 on ClinicalTrials.gov