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Enlicitide plus rosuvastatin for people with high cholesterol

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT07216482

This study will test whether adding the new medicine enlicitide to the standard statin rosuvastatin lowers LDL cholesterol more than a placebo in adults with high cholesterol.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment975 (estimated)
Ages18 Years to 64 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations89 sites (Birmingham, Alabama and 88 other locations)
Trial IDNCT07216482 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, placebo-controlled study gives adults with hyperlipidemia either enlicitide or a matching placebo alongside rosuvastatin to measure effects on LDL-C. Participants are assigned to receive enlicitide plus rosuvastatin or placebo plus rosuvastatin and will have blood tests to track LDL-C levels over the treatment period. The use of matching placebos helps isolate the effect of enlicitide when added to standard statin therapy. The primary outcome is the change in low-density lipoprotein cholesterol (LDL-C) compared with placebo.

Who should consider this trial

Good fit: Adults with high cholesterol who can take a statin and meet the study's health and lab criteria (for example, no active liver disease, no certain genetic familial hypercholesterolemia, and no recent heart failure hospitalization) are the intended participants.

Not a fit: People who cannot take statins, have certain genetic forms of familial hypercholesterolemia, active liver disease, neuromuscular conditions, HIV, or recent heart failure hospitalization are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If successful, adding enlicitide to rosuvastatin could lower LDL cholesterol more than statin alone and potentially reduce cardiovascular risk.

How similar studies have performed: Other trials combining novel lipid-lowering agents with statins have demonstrated LDL-C reductions, but enlicitide's specific benefits are still being tested in this Phase 3 program.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 88 other locations

+39 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hyperlipidemia
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.