Recruiting

Enlicitide Decanoate and Rosuvastatin for Hyperlipidemia Treatment

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Study AimThis 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
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

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

Summary

Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: December 25, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 11, 2025Actual 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: December 25, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different combinations of treatments to see how they work together. This approach helps researchers determine whether a combination of treatments is more effective than a single treatment alone.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 64 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hyperlipidemias
Metabolic Diseases
Nutritional and Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Criteria
1 inclusion criteria required to participate
Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.
8 exclusion criteria prevent from participating
Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.
Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Screening or plans to initiate an LDL-C apheresis program.
Had a heart failure hospitalization within 3 months before Screening.
Has received any medication that may interact with rosuvastatin within 5 half-lives prior to Screening or is planning to initiate such treatment.

Show More Criteria

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.

Oral Tablet

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

Oral Tablet

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

Oral Capsule

Oral Tablet
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.

Oral Tablet

Oral Capsule
Study Objectives
Primary Objectives

Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C between participants treated with enlicitide and rosuvastatin versus placebo.
Secondary Objectives

Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C.

Blood samples will be collected at baseline and at Week 8 to assess mean percent change in ApoB.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Blood samples will be collected at baseline and at Week 12 to assess mean percent change in LDL-C.

Blood samples will be collected at baseline and at Week 8 to assess mean percent change in non-HDL-C.

Blood samples will be collected at baseline and at Week 8 to assess percent change in Lp(a).

Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C \<70 mg/dL and ≥50% reduction from baseline.

Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C \<55 mg/dL and ≥50% reduction from baseline.

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 53 locations
Recruiting
Central Research Associates ( Site 0009)Birmingham, United StatesSee the location
Recruiting
G&L Research ( Site 0024)Foley, United States
Recruiting
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)Phoenix, United States
Recruiting
Alliance for Multispecialty Research LLC ( Site 0049)Tempe, United States
Recruiting
53 Study Centers