Recruiting

Enlicitide Decanoate and Rosuvastatin for Hyperlipidemia Treatment

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Study Aim

This clinical trial aims to test if Enlicitide Decanoate combined with Rosuvastatin is effective in treating high cholesterol levels (hyperlipidemia) compared to a placebo, by measuring the change in LDL-cholesterol after 8 weeks.

What is being tested

Enlicitide

+ Placebo for Rosuvastatin

+ Rosuvastatin

Drug
Who is being recruted

Hyperlipidemias+2

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 64 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 11, 2025

Actual date on which the first participant was enrolled.

This study focuses on people with hyperlipidemia, a condition where there are high levels of fatty substances in the blood, including low-density lipoprotein cholesterol (LDL-C), often called "bad cholesterol." The study aims to test whether a new medicine, enlicitide, when used together with the commonly prescribed drug rosuvastatin, can lower LDL-C levels more effectively than rosuvastatin alone. This is important because reducing LDL-C levels can lower the risk of heart disease and improve heart health. Participants in the study will be randomly assigned to receive either the combination of enlicitide and rosuvastatin or a placebo with rosuvastatin. A placebo is a harmless pill that looks like the real medicine but doesn’t contain any active ingredients. This helps researchers determine the true effects of the new medicine. The study will closely monitor changes in LDL-C levels in participants' blood to evaluate the effectiveness of the treatment. This process will ensure a clear understanding of how well the new combination works compared to the standard treatment alone.

Official TitleA 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
NCT07216482
Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

975 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism Disorders

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.

Group II

Experimental
Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.

Group III

Active Comparator
Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.

Group IV

Placebo
Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 87 locations

Recruiting

William Harvey Heart Centre ( Site 0800)

London, United KingdomOpen William Harvey Heart Centre ( Site 0800) in Google Maps
Recruiting

Lakeside Surgery ( Site 0802)

Corby, United Kingdom
Recruiting

Central Research Associates ( Site 0009)

Birmingham, United States
Recruiting

G&L Research ( Site 0024)

Foley, United States
Recruiting
87 Study Centers