Study of MK-0616 for Adults with Familial Hypercholesterolemia

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What is this study about?

This clinical trial is focused on studying a condition known as Heterozygous Familial Hypercholesterolemia (HeFH), which is a genetic disorder that causes high levels of low-density lipoprotein cholesterol (LDL-C), often referred to as “bad cholesterol.” The study is testing 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 evaluate how effective and safe MK-0616 is in reducing LDL-C levels in adults with HeFH.

Participants in the study will be randomly assigned to receive either the MK-0616 tablet or a placebo, which looks like the MK-0616 tablet but does not contain the active substance. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will last for a total of 52 weeks, with the main focus on changes in LDL-C levels at Week 24 and Week 52.

Throughout the study, participants will have regular check-ups to monitor their cholesterol levels and overall health. The study will also track any side effects or adverse events that may occur. The goal is to determine if MK-0616 can safely and effectively lower LDL-C levels in people with HeFH, potentially offering a new treatment option for managing this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of heterozygous familial hypercholesterolemia and a stable dose of lipid-lowering therapies.

Participants must have a certain level of low-density lipoprotein cholesterol (LDL-C) and be on a moderate- or high-intensity statin medication.

2 randomization and medication

Participants are randomly assigned to receive either the study medication MK-0616 or a placebo. Both are administered as film-coated tablets taken orally.

The dosage and frequency of administration are determined by the study protocol.

3 treatment period

The treatment period lasts for 24 weeks, during which the main objective is to evaluate the change in LDL-C levels.

Participants continue their existing lipid-lowering therapies without changes.

4 monitoring and assessments

Regular monitoring occurs throughout the study to assess the efficacy and safety of the treatment.

Participants are evaluated for any adverse events and changes in cholesterol levels.

5 end of treatment evaluation

At the end of 24 weeks, a primary assessment is conducted to measure the mean percent change in LDL-C from baseline.

Secondary assessments may include changes in other cholesterol-related markers and the percentage of participants achieving specific LDL-C targets.

6 extended follow-up

An extended follow-up period may continue up to 52 weeks to further evaluate the long-term effects of the treatment.

Additional assessments are conducted to monitor changes in cholesterol levels and any long-term adverse events.

Who Can Join the Study?

The patient must have a possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH). This is a genetic condition that causes high cholesterol levels, and the diagnosis should be based on a method accepted locally.
The patient must have an LDL-C level of 55 mg/dL or higher, or 70 mg/dL or higher, depending on their medical history. LDL-C stands for low-density lipoprotein cholesterol, often called “bad” cholesterol.
The patient must be treated with a moderate- or high-intensity statin medication. Statins are drugs used to lower cholesterol levels in the blood.
The patient must be on a stable dose of all background lipid-lowering therapies (LLTs) with no planned changes in medication. LLTs are treatments used to reduce fats, including cholesterol, in the blood.

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Salut Sant Joan De Reus	Reus	Spain
Oslo University Hospital Hf	Oslo	Norway
University Of Debrecen	Debrecen	Hungary
Nordlandssykehuset HF	Bodo	Norway
University Of Szeged	Szeged	Hungary
Dijklander Ziekenhuis	Hoorn	The Netherlands
Semmelweis University	Budapest	Hungary
Apddfoodu Uer	Amsterdam	The Netherlands
Saaucnatx Roynthn Uprtsnyuxf Mqrvrtw Ctccoo	Nijmegen	The Netherlands
Hgdkltev Utknqlfbxy Ceihadl Hzqkoduc	Helsinki	Finland
Egzoqen Ufoltuuusqpx Mpwxsic Cjfpcra Rtjocpezi (pvcvvlh Mwk	Rotterdam	The Netherlands
Iookdleib Fim Cdjrebnm Alx Esqavukabbxu Mexukrgl	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.09.2023
Finland	Not recruiting	01.09.2023
Hungary	Not recruiting	01.09.2023
Norway	Not recruiting	01.09.2023
Spain	Not recruiting	01.09.2023
The Netherlands	Not recruiting	01.09.2023

Trial locations

Investigated drugs:

Enlicitide Chloride

MK-0616 is a medication being studied for its ability to lower LDL cholesterol levels in adults with a condition called heterozygous familial hypercholesterolemia. This condition causes high levels of cholesterol in the blood, which can lead to heart disease. The trial aims to see how well MK-0616 works in reducing cholesterol levels and to check if it is safe and well-tolerated by patients over a period of 24 weeks.

Heterozygous Familial Hypercholesterolemia – This is a genetic disorder characterized by high levels of low-density lipoprotein cholesterol (LDL-C) in the blood. It is caused by a mutation in one of the genes responsible for removing LDL-C from the bloodstream. As a result, individuals with this condition have elevated cholesterol levels from birth. Over time, the excess cholesterol can deposit in the walls of arteries, leading to atherosclerosis. This buildup can cause narrowing and hardening of the arteries, potentially affecting blood flow. The condition is typically inherited from one affected parent, making it a dominant genetic trait.

Trial ID:

2022-502782-14-00

Protocol code:

MK-0616-017

NCT ID:

NCT05952869

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of MK-0616 for Adults with Familial Hypercholesterolemia

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