A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037) (NCT07216482) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
United States, Argentina, Australia975 participantsStarted 2025-11-11
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing enlicitide combined with rosuvastatin — is rosuvastatin already part of my treatment plan, and does that affect whether this combination might be worth discussing for me?
2Since this is a Phase 3 trial, what does that mean for how much is already known about enlicitide's safety and effectiveness compared to what we still don't know?
3The trial is no longer actively recruiting — are there any other ongoing or upcoming studies of enlicitide, or similar PCSK9-targeting approaches, that I might still be eligible to discuss with you?
4The primary goal is to measure LDL-C reduction at just 8 weeks — does that short timeframe tell us enough about long-term outcomes, and how would you weigh that against my current treatment options?
5Are there standard cholesterol-lowering medications or combinations that might achieve similar LDL-C goals for me right now, while longer-term evidence on enlicitide continues to develop?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)