Study on the Effects 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 the condition known as Hypercholesterolemia, which is characterized by high levels of cholesterol in the blood. The trial will evaluate a treatment called MK-0616, a medication provided in the form of a film-coated tablet. The purpose of the study is to assess how effective and safe MK-0616 is for adults who have high cholesterol levels.

Participants in the study will be randomly assigned to receive either the MK-0616 treatment or a placebo, which is a substance with no active medication. The study will last for a total of 52 weeks, with key assessments taking place at Week 24 and Week 52. During this time, the main focus will be on observing changes in the levels of low-density lipoprotein cholesterol (often referred to as “bad” cholesterol) in the participants’ blood. Additionally, the study will monitor any side effects or adverse events that participants may experience.

The trial aims to provide valuable information on whether MK-0616 can effectively lower cholesterol levels and improve the health of individuals with Hypercholesterolemia. By the end of the study, researchers hope to determine if this treatment can be a safe and beneficial option for managing high cholesterol.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to cholesterol levels and cardiovascular health history.

Participants must have a history of cardiovascular events or be at risk, with specific cholesterol levels as outlined in the study criteria.

2 initial assessment

An initial assessment is conducted to establish baseline cholesterol levels, including low-density lipoprotein cholesterol (LDL-C).

Participants must be on a stable dose of any lipid-lowering therapies for at least 30 days before this assessment.

3 randomization and treatment

Participants are randomly assigned to receive either the study medication, MK-0616, or a placebo.

The medication is administered orally in the form of a film-coated tablet.

4 medication administration

The study medication or placebo is taken as directed, with specific dosage and frequency determined by the study protocol.

Participants continue their existing lipid-lowering therapies unless otherwise instructed.

5 follow-up assessments

Regular follow-up assessments are conducted to monitor cholesterol levels and any potential side effects.

Primary assessments focus on the percent change in LDL-C at week 24, with additional assessments at week 52.

6 completion of study

The study concludes with a final assessment to evaluate the overall efficacy and safety of the treatment.

Participants’ cholesterol levels and any adverse events are reviewed to determine the outcomes of the study.

Who Can Join the Study?

The patient must have high cholesterol (also known as hypercholesterolemia).
The patient should have a history of a major atherosclerotic cardiovascular disease (ASCVD) event, which is a condition where the arteries become narrowed or blocked, or be at intermediate to high risk for developing such an event.
If the patient has a history of a major ASCVD event, their LDL-C (a type of cholesterol) should be 55 mg/dL or higher.
If the patient does not have a history of a major ASCVD event, their LDL-C should be 70 mg/dL or higher.
At the time of screening, the patient should be either:

Treated with a moderate or high-intensity statin (a medication to lower cholesterol) with or without other cholesterol-lowering therapies.
Treated with a low-intensity statin with or without other therapies, with proof of intolerance to moderate or high-intensity statins.
Not receiving statins, with proof of intolerance to any dose of at least two different statins, including at least one at the lowest approved dose.

If the patient is on any cholesterol-lowering therapies (like a statin or ezetimibe), they should be on a stable dose for at least 30 days before screening and should not plan to change the medication or dose during the study.
The study is open to both male and female participants.
The study includes participants from vulnerable populations, which may include groups like the elderly or those with certain health conditions.

Who Cannot Join the Study?

Individuals with certain medical conditions that might interfere with the study.
People who are currently taking medications that could affect the study results.
Participants who have had recent surgeries or medical procedures that might impact the study.
Individuals with a history of allergic reactions to similar medications.
Pregnant or breastfeeding women.
People with severe liver or kidney problems.
Participants who are unable to follow the study procedures or attend scheduled visits.
Individuals with a history of drug or alcohol abuse.
People who are currently participating in another clinical trial.

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
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Klinische Forschung Berlin GbR	Berlin	Germany
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
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
Ajqmqay Ovexjkwpdaz Usdtecozyiqzv Csfauwrfxudv Dlhvj Siveff E Dcrky Sdvkmif Dx Tofrbh	Turin	Italy
Ukp Kkwcpeuxt Fmidvdbwd	Essen	Germany
Hlfaiphdw &wjdv Dgdaeecnjneujjeorpjfepzmvf Hwkjhjzrgxt	Hohenmölsen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	25.09.2023
Italy	Not yet recruiting	25.09.2023
Spain	Not yet recruiting	25.09.2023

Trial locations

Investigated drugs:

Mk-0616

MK-0616 is a medication being studied for its ability to lower cholesterol levels in adults with high cholesterol. The trial aims to assess how well this medication can reduce LDL cholesterol, which is often referred to as “bad” cholesterol, over a period of 24 weeks. The study also focuses on understanding the safety and tolerability of this medication for patients.

Hypercholesterolemia – This condition is characterized by high levels of cholesterol in the blood, particularly low-density lipoprotein cholesterol (LDL-C), 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 ID:

2022-502777-42-00

Protocol code:

MK-0616-013

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?