BridgeMD
A clinical study of enlicitide in people with high cholesterol (MK-0616-037)
EU CTIS ID: 2025-521495-54-00
What this study is testing
To compare the efficacy of enlicitide + rosuvastatin against placebo on mean percent change from baseline LDL-C at Week 8.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.
- Is an individual of any sex/gender, from 18 years to 64 years age inclusive.
You likely can't join if
- 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.
See the full eligibility criteria
- Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.
- Is an individual of any sex/gender, from 18 years to 64 years age inclusive.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- New Zealand
- Australia
- Israel
- Canada
- United States
- Turkey
- Brazil
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; New Zealand; Australia; Israel; Canada; United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.