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Study on MK-0616, Ezetimibe, and Bempedoic Acid 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. The study will evaluate the effectiveness and safety of a new treatment called MK-0616 compared to other existing treatments, including Ezetimibe, Bempedoic Acid, and a combination of Ezetimibe and Bempedoic Acid. The purpose of the study is to see how these treatments affect cholesterol levels, specifically low-density lipoprotein cholesterol (LDL-C), over a period of 56 days.

Participants in the study will be randomly assigned to receive either MK-0616, Ezetimibe, Bempedoic Acid, or a combination of Ezetimibe and Bempedoic Acid. Some participants may receive a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment each participant is receiving, to ensure unbiased results. The treatments will be taken orally, and the study will monitor changes in cholesterol levels and any side effects experienced by participants.

The main goal is to measure the change in LDL-C levels from the start of the study to Day 56. Secondary goals include observing changes in other cholesterol-related markers and the number of participants who achieve specific cholesterol level targets. The study will also track any adverse events, which are unwanted effects that may occur during the trial. This research aims to provide valuable information on the effectiveness of MK-0616 compared to existing treatments for managing high cholesterol.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being tested.

  2. Step 2

    Treatment administration

    Participants receive one of the following treatments: MK-0616, ezetimibe, bempedoic acid, or a combination of ezetimibe and bempedoic acid. Each medication is taken orally in the form of a film-coated tablet.

    The dosage and frequency of administration are determined by the study protocol and are consistent throughout the trial period.

  3. Step 3

    Monitoring and assessments

    Participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes measuring the mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Day 56.

    Additional assessments include changes in other cholesterol-related markers such as ApoB, non-HDL-C, and Lp(a).

  4. Step 4

    Evaluation of results

    The primary goal is to evaluate the mean percent change in LDL-C at Day 56. Secondary outcomes include the percentage of participants achieving specific LDL-C targets and the number of participants experiencing adverse events.

    The study aims to determine the efficacy of MK-0616 compared to the other treatments.

  5. Step 5

    Completion of study

    The study is estimated to conclude by September 21, 2025. Participants will have completed all required assessments and treatments by this date.

Who can join the trial?

5 criteria

  • The patient must have a history of a major **atherosclerotic cardiovascular disease (ASCVD)** event, which is a condition where the arteries become narrowed or blocked, or if they do not have such a history, they must be at intermediate to high risk for developing a first major ASCVD event.
  • The patient must have **fasted lipid values** checked by a central laboratory at the first visit. If they have a history of a major ASCVD event, their **low-density lipoprotein (LDL-C)**, which is often called "bad cholesterol," should be 55 mg/dL or higher. If they do not have a history of a major ASCVD event, their LDL-C should be 70 mg/dL or higher.
  • The patient must be treated with a low, moderate, or high intensity **statin**, which is a type of medication used to lower cholesterol, with or without other non-statin lipid-lowering therapies.
  • The patient must be on a stable dose of all background lipid-lowering therapies, with no planned changes in medication or dose during the study.
  • The patient can be of any sex or gender and must be at least 18 years old at the time they provide informed consent to participate in the study.

Who cannot join the trial?

10 criteria

  • Individuals with a history of **allergic reactions** to any of the study medications.
  • People who have **severe liver disease**. This means the liver is not working well.
  • Participants with **uncontrolled high blood pressure**. This means blood pressure that is not managed well with medication.
  • Individuals who have had a **heart attack** or **stroke** in the last 3 months.
  • People with **kidney problems** that require dialysis. Dialysis is a treatment that does the work of the kidneys.
  • Women who are **pregnant** or **breastfeeding**.
  • Participants who are currently taking other medications that might interfere with the study drugs.
  • Individuals with a history of **drug or alcohol abuse** in the past year.
  • People who have participated in another clinical trial in the last 30 days.
  • Anyone who is not able to follow the study procedures or attend the required visits.
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Investigated drugs

  • MK-0616

    is an investigational medication being studied for its ability to lower cholesterol levels in the blood. It is being compared to other treatments to see how well it can reduce low-density lipoprotein (LDL-C), which is often referred to as "bad" cholesterol. The goal is to determine if MK-0616 is more effective than the other treatments in lowering cholesterol levels.

  • Ezetimibe

    is a medication used to lower cholesterol levels in the blood. It works by reducing the amount of cholesterol absorbed by the intestines. This medication is often used when diet and other lifestyle changes are not enough to lower cholesterol levels.

  • Bempedoic Acid

    is a medication that helps to lower cholesterol levels by inhibiting an enzyme involved in cholesterol production in the liver. It is used for people who need additional help in managing their cholesterol levels, especially when other treatments are not sufficient.

  • Ezetimibe and Bempedoic Acid

    is a combination therapy that uses both ezetimibe and bempedoic acid together to lower cholesterol levels. This combination is used to provide a more comprehensive approach to reducing cholesterol by using two different mechanisms to lower the amount of cholesterol in the blood.

What is already known about the treatment

  • MK-0616

    This medication is administered orally and is currently in Phase 3 clinical trials. It is being studied for its effectiveness in treating hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. MK-0616 works by targeting specific pathways to reduce low-density lipoprotein (LDL) cholesterol levels. It is classified as a lipid-lowering agent and is being compared to other medications like ezetimibe and bempedoic acid in terms of efficacy and safety.

  • Ezetimibe

    Ezetimibe is an oral medication used to lower cholesterol levels, specifically targeting hypercholesterolemia. It works by reducing the absorption of cholesterol in the small intestine, leading to decreased levels of LDL cholesterol in the blood. Ezetimibe is well-established in medical literature and is classified as a cholesterol absorption inhibitor. It is often used in combination with other lipid-lowering agents to enhance its effectiveness.

  • Bempedoic Acid

    This medication is taken orally and is used to treat hypercholesterolemia by lowering LDL cholesterol levels. Bempedoic acid functions by inhibiting an enzyme involved in cholesterol synthesis in the liver, which helps reduce cholesterol levels in the bloodstream. It is classified as an ATP-citrate lyase inhibitor and is often used when other cholesterol-lowering treatments are insufficient.

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 is often influenced by genetic factors, diet, and lifestyle choices. It may not present noticeable symptoms initially, but it can be detected through blood tests measuring cholesterol levels. Managing cholesterol levels is crucial to prevent the progression of related health issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504920-25-00Protocol codeMK-0616-018Estimated enrolment320 patientsSponsorMerck Sharp & Dohme LLC

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