A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)

NCTNCT07216482Other id0616-037Other idU1111-1319-9502Other id2025-521495-54-00Other idMK-0616-037

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 3
Enrollment: 996 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Triple masking
Countries: 11 countries
United States, Argentina, Australia, Brazil, Canada, Hungary, Israel, New Zealand, Spain, Turkey (Türkiye), United Kingdom
Start: 11 Nov 2025
Primary completion: 3 Aug 2026
Completion: 5 Nov 2026 (estimated)
First posted: 14 Oct 2025
Last update posted: 1 Sept 2026
Conditions: Hyperlipidemia

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027

Ph 3
A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
NCT07216482
11 Nov 2025 to est. 5 Nov 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

EnlicitideDrug
RosuvastatinDrug
Placebo for EnlicitideDrug
Placebo for RosuvastatinDrug

Arms4

Experimental
Enlicitide
Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
Experimental
Enlicitide + Rosuvastatin
Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
Active comparator
Rosuvastatin
Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
Placebo comparator
Placebo
Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)
Time frame · Baseline and Week 8
Registry description
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 outcomes(9)

Mean Percent Change from Baseline in LDL-C at Week 8
Time frame · Baseline and Week 8
Registry description
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C.
Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8
Time frame · Baseline and Week 8
Registry description
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in ApoB.
Number of Participants with One or More Adverse Events (AEs)
Time frame · Up to approximately 20 weeks
Registry description
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.
Number of Participants who Discontinue Study Drug Due to One or More AEs
Time frame · Up to approximately 12 weeks
Registry description
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.
Mean Percent Change from Baseline in LDL-C at Week 12
Time frame · Baseline and Week 12
Registry description
Blood samples will be collected at baseline and at Week 12 to assess mean percent change in LDL-C.
Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8
Time frame · Baseline and Week 8
Registry description
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in non-HDL-C.
Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8
Time frame · Baseline and Week 8
Registry description
Blood samples will be collected at baseline and at Week 8 to assess percent change in Lp(a).
Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8
Time frame · Baseline and Week 8
Registry description
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.
Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8
Time frame · Baseline and Week 8
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 64 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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