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

Verified siteInvestigationalNo placebo
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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 the condition known as hypercholesterolemia, which is a medical term for having high levels of cholesterol in the blood. The trial will use a treatment called MK-0616, which is a film-coated tablet containing the active substance enlicitide chloride. The purpose of the study is to evaluate the safety and tolerability of this treatment in adults who have already completed a previous trial involving MK-0616.

Participants in this study will continue to take the MK-0616 tablet as part of an open-label extension, meaning that both the participants and the researchers know what treatment is being administered. The study will monitor participants for any adverse events, which are any unwanted effects that may occur during the trial. Additionally, the study will assess changes in cholesterol levels, specifically looking at low-density lipoprotein cholesterol (LDL-C), which is often referred to as "bad" cholesterol, and other related markers.

The trial is designed to last for several years, allowing researchers to gather comprehensive data on the long-term effects of MK-0616. Participants will be regularly monitored to ensure their safety and to track the effectiveness of the treatment in managing their cholesterol levels. This study aims to provide valuable information on how well MK-0616 works and how safe it is for people with high cholesterol.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing a previous MK-0616 study with at least 80% compliance.

    Eligibility is confirmed based on completion of the parent study and adherence to its protocol.

  2. Step 2

    Medication administration

    The medication used in this study is called MK-0616, which is a film-coated tablet.

    The active substance in the medication is enlicitide chloride.

    The medication is taken orally, meaning it is swallowed.

  3. Step 3

    Treatment duration

    The study is an open-label extension, meaning participants and researchers know the treatment being administered.

    The study aims to evaluate the safety and tolerability of the treatment over time.

  4. Step 4

    Monitoring and assessments

    Participants are monitored for any adverse events, which are any unwanted effects experienced during the study.

    The number of participants who discontinue the study drug due to adverse events is recorded.

  5. Step 5

    Evaluation of cholesterol levels

    The study measures changes in low-density lipoprotein cholesterol (LDL-C) from the baseline of the parent study at Week 8.

    Other cholesterol-related measurements include non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein(a) (Lp[a]).

    The percentage of participants achieving specific LDL-C reduction targets is also evaluated.

  6. Step 6

    Study duration

    The estimated end date for the study is October 13, 2028.

    Recruitment for the study is expected to start on October 24, 2024.

Who can join the trial?

5 criteria

  • The patient must have completed a previous study involving the treatment called MK-0616. This includes finishing all the required tests and procedures in that study.
  • The patient must have followed the rules and instructions of the previous study at least 80% of the time. This means they need to have been mostly compliant with the study requirements.
  • The patient can be of any gender, meaning both males and females are eligible to participate.
  • The patient must be within the specified age range, which includes adults and older adults.
  • The patient should not belong to a group considered vulnerable, which means they should not be in a situation that might make it difficult for them to make decisions about their participation.

Who cannot join the trial?

10 criteria

  • Patients with certain medical conditions that are not compatible with the study.
  • Individuals who are not within the specified age range for the study.
  • Participants who are part of a vulnerable population, which means they might need special protection or care.
  • People who do not meet the specific health requirements needed for the study.
  • Individuals who are taking medications or treatments that could interfere with the study.
  • Participants who have a history of certain medical issues that could affect the study results.
  • Women who are pregnant or breastfeeding, as the study may not be safe for them.
  • Individuals who have participated in another clinical trial recently, as this could affect the study outcomes.
  • People who are unable to follow the study procedures or instructions.
  • Anyone who has allergies or reactions to the study medication or similar treatments.
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Investigated drugs

MK-0616 is a medication being studied for its safety and effectiveness in adults with high cholesterol levels. The trial aims to understand how well this medication can be tolerated by patients and its potential benefits in managing cholesterol.

What is already known about the treatment

MK-0616 – This medication is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. MK-0616 is in the investigational stage, with ongoing research to determine its role in medical practice. It is primarily indicated for lowering cholesterol levels to reduce the risk of cardiovascular diseases. The drug works by inhibiting a specific enzyme involved in cholesterol production, thereby reducing overall cholesterol levels in the body. MK-0616 is classified as a lipid-lowering agent.

Investigated diseases

Hypercholesterolemia – This condition is characterized by high levels of cholesterol in the blood, particularly low-density lipoprotein cholesterol (LDL-C), which is often referred to as "bad" cholesterol. Over time, the excess cholesterol can build up in the walls of arteries, leading to atherosclerosis, which is the narrowing and hardening of the arteries. This process can reduce or block blood flow, potentially leading to complications in the cardiovascular system. Hypercholesterolemia can be influenced by genetic factors, diet, lifestyle, and other health conditions. It often progresses silently without symptoms until significant arterial blockage occurs. Regular monitoring of cholesterol levels is important to manage and understand the progression of this condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504922-20-00Protocol codeMK-0616-019Estimated enrolment3 453 patientsSponsorMerck Sharp & Dohme LLC

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