NCT07821944RecruitingPhase 3
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate in Adults With Hyperlipidemia in India
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 9 Sept 2026
- Start date
- 15 Oct 2026
- Primary completion date
- 26 Nov 2027
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07821944
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 150
- From 15 Oct 2026 to the primary completion date, 26 Nov 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Has a history of nephrotic syndrome
- Has poorly controlled diabetes mellitus
Age
- Is actively receiving chemotherapy for malignancy or has a history of malignancy ≤3 years before Screening
Other
- The main exclusion criteria include but are not limited to the following:
- Has hyperthyroidism or inadequately controlled hypothyroidism
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KLES Prabhakar Kore Hospital & Medical Research Centre [M] ( Site 1004) Coordinator of this site? Confirm its status | Belagavi | India | Recruiting |
| Sir Ganga Ram Hospital ( Site 1001) Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.