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Study of MK-0616 for Adults with Familial Hypercholesterolemia

Verified siteInvestigational

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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 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.

The research process

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

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

4 criteria

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.

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Verified sites

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Responsive
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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Investigated drugs

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.

Enlicitide Chloride

What is already known about the treatment

MK-0616 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating adults with Heterozygous Familial Hypercholesterolemia (HeFH). It is in the Phase 3 stage of clinical trials, which means it is being tested for efficacy and safety before potential approval for general medical use. The main therapeutic indication for MK-0616 is to lower LDL cholesterol levels in individuals with HeFH. At the molecular level, MK-0616 works by inhibiting a specific protein involved in cholesterol regulation, thereby reducing the amount of LDL cholesterol in the bloodstream. It is classified pharmacologically as a cholesterol-lowering agent.

Investigated diseases

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.