Ireland
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Recruiting Phase 3

A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)

NCT07821944 · tracked via the Priya Life Science India tracker
Phase
Phase 3
Started
2026-10-15
Last updated
2026-11-02

Condition(s) studied

HyperlipidemiaHypercholesterolemia

Investigational drug(s) / intervention(s)

Enlicitide Decanoate →Placebo

Enlicitide Decanoate: Oral administration

Placebo: Oral administration

Study summary

Researchers are looking for new ways to treat high cholesterol. Cholesterol is a type of fat in the blood.

Enlicitide (also known as enlicitide decanoate or MK-0616), the study medicine, is in a class of medicines designed to lower low-density lipoprotein cholesterol (LDL-C). LDL-C is sometimes called "bad cholesterol."

The goal of this study is to learn if enlicitide works better than placebo to lower the amount of LDL-C in a person's blood. Researchers also want to learn about the safety of enlicitide and if people tolerate it.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * History of a major atherosclerotic cardiovascular disease (ASCVD) event or if no history of a major ASCVD event, has one or more of the following: possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH), diabetes mellitus, stable angina pectoris, transient ischemic attack or symptomatic peripheral arterial disease * Has a low-density lipoprotein cholesterol (LDL-C) ≥55 mg/dL or ≥70 mg/dL depending on medical history * Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance * If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Had a heart failure hospitalization within 3 months before Screening * Has unstable angina, a myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening * Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program * Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors * Has a history of nephrotic syndrome * Has poorly controlled diabetes mellitus * Has hyperthyroidism or inadequately controlled hypothyroidism * Is actively receiving chemotherapy for malignancy or has a history of malignancy ≤3 years before Screening

Primary outcome measure(s)

  • Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 — Baseline and Week 24
    Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
  • Number of Participants with One or More Adverse Events (AEs) — Up to approximately 32 Weeks
    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 — Up to approximately 24 Weeks
    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.

Trial sites (2)

FacilityCityRegionStatus
KLES Prabhakar Kore Hospital & Medical Research Centre [M] ( Site 1004) Belagavi Karnataka Recruiting
Sir Ganga Ram Hospital ( Site 1001) New Delhi National Capital Territory of Delhi Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07821944 on ClinicalTrials.gov ↗ ← All trials in India