A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
Purpose
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.
Condition
- Hyperlipidemia
Eligibility
- Eligible Ages
- Between 18 Years and 64 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Provecta Research Network LLC ( Site 0022)
Houston, Texas 77027
Houston, Texas 77027
Contact:
Study Coordinator
346-735-8990
Study Coordinator
346-735-8990
Clinical Trials of Texas, Inc. ( Site 0010)
San Antonio, Texas 78229
San Antonio, Texas 78229
Contact:
Study Coordinator
210-949-0122
Study Coordinator
210-949-0122
More Details
- NCT ID
- NCT07216482
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC