Enlicitide (MK-0616) for adults with high cholesterol in India

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares enlicitide decanoate to placebo in adults with high LDL-C, many of whom have a history of ASCVD or related risk factors. Participants will receive injections of enlicitide or placebo and will be monitored for changes in LDL-C levels and safety over time. Eligible individuals are on stable statin therapy or have documented statin intolerance, with specific LDL-C thresholds required for enrollment. The study is conducted at two sites in India to evaluate efficacy and tolerability in this population.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.