Status:
RECRUITING
A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hyperlipidemia
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief 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 cal...
Eligibility Criteria
Inclusion
- Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.
Exclusion
- 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.
Key Trial Info
Start Date :
November 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
975 Patients enrolled
Trial Details
Trial ID
NCT07216482
Start Date
November 11 2025
End Date
March 1 2027
Last Update
January 5 2026
Active Locations (55)
Enter a location and click search to find clinical trials sorted by distance.
1
Central Research Associates ( Site 0009)
Birmingham, Alabama, United States, 35205
2
G&L Research ( Site 0024)
Foley, Alabama, United States, 36535
3
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
Phoenix, Arizona, United States, 85020
4
Alliance for Multispecialty Research LLC ( Site 0049)
Tempe, Arizona, United States, 85281