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Study on the Effectiveness and Safety of MK-0616 for Adults with High Cholesterol

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood, which can increase the risk of heart disease. The study will evaluate a new treatment called MK-0616, which is a film-coated tablet containing the active substance enlicitide chloride. The purpose of the study is to assess how effective and safe MK-0616 is in reducing cholesterol levels compared to a placebo.

Participants in the study will be randomly assigned to receive either MK-0616 or a placebo. The study will last for a total of 52 weeks, with the main focus on changes in low-density lipoprotein cholesterol (LDL-C) levels at Week 24. LDL-C is often referred to as "bad" cholesterol because high levels can lead to the buildup of cholesterol in arteries. The study will also monitor the safety and any side effects experienced by participants during this period.

Throughout the study, participants will have regular check-ups to monitor their cholesterol levels and overall health. The study aims to provide valuable information on whether MK-0616 can effectively lower cholesterol levels and improve heart health in individuals with hypercholesterolemia. This research could potentially lead to new treatment options for managing high cholesterol and reducing the risk of heart-related complications.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the study medication, MK-0616, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

    This process is double-blind, meaning neither you nor the study team will know which group you are in. This helps ensure the results are unbiased.

  2. Step 2

    Medication administration

    You will take the assigned tablet orally once a day. The tablet is a film-coated tablet.

    The duration of taking the medication is planned for 24 weeks initially, with a possible extension to 52 weeks depending on the study's progress and your participation.

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include blood tests to measure your LDL-C levels, which is a type of cholesterol.

    You will also be asked about any side effects or changes in your health. This is to ensure your safety and to gather data on the medication's effects.

  4. Step 4

    End of study evaluation

    At the end of the study period, you will have a final evaluation. This will include a comprehensive health check and a review of your cholesterol levels.

    The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who can join the trial?

11 criteria

  • Must have a condition called Hypercholesterolemia, which means having high levels of cholesterol in the blood.
  • Must be at least 18 years old.
  • Can be of any gender.
  • Must have either:
    • A history of a major atherosclerotic cardiovascular disease (ASCVD) event, which refers to serious heart or blood vessel problems.
    • If no history of a major ASCVD event, must have an intermediate to high risk of developing a first major ASCVD event.
    • If there is a history of a major ASCVD event, must have LDL-C (a type of cholesterol) levels of 55 mg/dL or higher.
    • If there is no history of a major ASCVD event, must have LDL-C levels of 70 mg/dL or higher.
    • At the time of screening, must be:
      • Treated with a moderate or high-intensity statin (a medication to lower cholesterol) with or without other lipid-lowering therapy (LLT).
      • Treated with a low-intensity statin with documentation of intolerance to a moderate or high-intensity statin.
      • Not receiving statins with documented evidence of intolerance to any dose of at least two different statins, with at least one at the lowest approved dose.
      • If on any LLTs (such as a statin and/or ezetimibe, another cholesterol-lowering medication), should be on a stable dose for at least 30 days before screening with no planned medication or dose change during the study.

Who cannot join the trial?

3 criteria

  • Patients with **hypercholesterolemia** (high cholesterol levels) cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
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Investigated drugs

MK-0616 is a medication being studied for its ability to lower cholesterol levels in the blood. Cholesterol is a type of fat that can build up in your blood vessels, leading to heart problems. This medication is designed to help reduce the amount of bad cholesterol, known as LDL-C, which can decrease the risk of heart disease. The study aims to see how well MK-0616 works in lowering cholesterol and to check if it is safe and well-tolerated by people who take it.

What is already known about the treatment

MK-0616 – MK-0616 is administered orally in the form of a tablet and is currently being studied in clinical trials for its effectiveness and safety in treating adults with high cholesterol levels, specifically hypercholesterolemia. This medication is in the late stages of research, known as Phase 3 trials, which means it is being tested on a larger group of people to confirm its benefits and monitor side effects. The main purpose of MK-0616 is to lower LDL cholesterol, often referred to as "bad" cholesterol, which can help reduce the risk of heart disease. It works by inhibiting a specific protein in the liver that is involved in cholesterol production, thereby reducing the amount of cholesterol released into the bloodstream. MK-0616 is classified as a cholesterol-lowering drug, and its development is focused on providing a new option for managing cholesterol levels in patients who may not respond well to existing treatments.

Investigated diseases

Hypercholesterolemia – Hypercholesterolemia is a condition characterized by high levels of cholesterol in the blood. Cholesterol is a fatty substance that is essential for building cells, but too much of it can lead to health problems. In hypercholesterolemia, excess cholesterol can deposit in the walls of blood vessels, leading to atherosclerosis, which is the narrowing and hardening of the arteries. This condition progresses as cholesterol continues to accumulate, potentially leading to reduced blood flow. Over time, this can affect various organs and tissues, particularly the heart and brain. The progression of hypercholesterolemia is often silent, with no obvious symptoms until significant damage has occurred.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502777-42-01Protocol codeMK-0616-013Estimated enrolment2 760 patientsSponsorMerck Sharp & Dohme LLC

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