Enlicitide compared with placebo for high cholesterol in adults in India
Tests enlicitide against placebo for lowering LDL cholesterol in adults with high cholesterol.
Plain-language title generated from the registry record
Registry title: A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Key facts
- Where
- Belagavi and New Delhi, IndiaSee the 2 sites
- Phase
- Phase 3
Where in India
- KLES Prabhakar Kore Hospital & Medical Research Centre [M] (Site 1004)Belagavi, IndiaTaking people
- Sir Ganga Ram Hospital (Site 1001)New Delhi, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07821944
- Record updated
- 2 November 2026
- Original description
Researchers are looking for new ways to treat high cholesterol. Cholesterol is a type of fat in the blood.Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate in Adults With Hyperlipidemia in India
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.
Inclusion: 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: 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; Is actively receiving chemotherapy for malignancy or has a history of malignancy ≤3 years before Screening; The main exclusion criteria include but are not limited to the following:; Has hyperthyroidism or inadequately controlled hypothyroidism.