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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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Klinische Forschung Berlin GbR Berlin Germany
Centro Cardiologico Monzino S.p.A. Milan Italy
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Zentralklinik Bad Berka GmbH Bad Berka Germany
Hospital Universitario 12 De Octubre Madrid Spain
ARNAS Garibaldi Di Catania Catania Italy
Eap Osona Sud Alt Congost S.L.P. Centelles Spain
Area Sanitaria Da Coruna E Cee A Coruna Galicia Spain
Adcfadr Oaskgjswash Ugfvzukwmyyys Chlqgfllpjmk Dgfbe Svkcfv E Daipa Sfquvad Dh Tuiyoq Turin Italy
Ure Kpirpglzs Ftggvtozj Essen Germany
Hyrqvapva &pzhw Dvumceybbtodtchixjfywgnrgb Hbcpccbvoej Hohenmölsen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.11.2023
Italy Italy
Not recruiting
01.11.2023
Spain Spain
Not recruiting
01.11.2023

Trial locations

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.

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 ID:
2022-502777-42-01
Protocol code:
MK-0616-013
NCT ID:
NCT05952856
Trial Phase:
Therapeutic confirmatory (Phase III)

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