Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

This research study is investigating a new medication called MK-0616. It's designed for adults who have high cholesterol, often called 'hypercholesterolemia'. The main goal is to find out if MK-0616 is effective at lowering 'bad' cholesterol (LDL-C) and how safe it is to use. To do this, some participants will receive the new medicine, while others will get a placebo (a dummy pill with no active ingredients). Nobody, including the doctors and nurses, will know who is getting which treatment until the study is over. Researchers will closely watch changes in cholesterol levels and record any side effects over 24 weeks and then again at 52 weeks. This helps determine if MK-0616 could be a helpful and safe treatment for people with high cholesterol.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

299

Start

20 Dec 2023

Hypercholesterolemia

What is this study about?

This clinical trial is designed to investigate a new medication, MK-0616, for adults who have high cholesterol. High cholesterol means you have too much of certain fats in your blood, which can increase your risk of heart problems. The study aims to understand two main things: firstly, how effective MK-0616 is at lowering the 'bad' type of cholesterol, known as LDL-C, and secondly, how safe it is for people to take.

To get clear results, the study is set up so that some people will receive the new medicine (MK-0616), and others will receive a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers compare the effects of the new medicine against doing nothing, without any bias. Neither you nor the study team will know which treatment you are receiving until the study has finished. This is called a 'double-blind' study.

The main focus will be on how much LDL-C levels change after 24 weeks. Researchers will also be carefully monitoring any side effects that people might experience. They will also look at other types of cholesterol over a longer period, up to 52 weeks, to get a full picture of the medicine's effects. The information gathered from this study is crucial for deciding if MK-0616 could become a new treatment option for people with high cholesterol in the future.

Key takeaways

This study is for adults with high cholesterol.
It tests a new medicine, MK-0616, against a dummy pill.
The main goals are to see if MK-0616 lowers 'bad' cholesterol and is safe.
Participation involves regular clinic visits for blood tests and health checks.
The study is 'double-blind', meaning neither you nor your doctor knows which treatment you get.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years and above. Gender is not a factor, meaning both men and women are welcome to participate if they meet the other study requirements. The most important condition for joining is having high cholesterol, a condition also known as hypercholesterolemia.

To make sure the study results are clear and reliable, there will be other specific medical requirements and health checks. For example, people with certain existing health conditions or those taking particular medications might not be able to participate. These criteria help to ensure the safety of participants and the quality of the study data.

It's important to remember that meeting the basic age and condition requirements doesn't guarantee entry into the study. A healthcare professional working on the study will need to screen you carefully to see if you are a good fit for all the detailed criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with high cholesterol (hypercholesterolemia)?
Are you able to attend regular clinic appointments?
Are you willing to potentially receive a dummy pill (placebo)?
Are you comfortable with regular blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to either receive the new medicine (MK-0616) or a dummy pill (placebo) – you won't know which one you're getting. You would take this study medicine regularly as instructed. Over the course of the study, you would have several visits to a clinic. These visits will involve blood tests to check your cholesterol levels and overall health, physical examinations, and discussions about how you're feeling and any side effects you might be experiencing. The main part of the study will last for 24 weeks, but researchers will continue to monitor some things for a total of 52 weeks. Your commitment ensures that valuable information can be gathered to understand the new medicine's effects.

Potential risks and benefits

Taking part in a clinical trial might offer you potential benefits, such as access to a new treatment before it's widely available, and your health will be closely monitored by a dedicated medical team. However, there are also potential risks; the new medicine might cause side effects, or it might not be effective for you. There is also the chance you could receive the placebo. Your decision to join is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Spain
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Unverified
Germany

Common questions

What is 'bad' cholesterol (LDL-C)?

LDL-C is often called 'bad' cholesterol because high levels can lead to a build-up of fatty deposits in your arteries, increasing your risk of heart disease.

What is a placebo?

A placebo is a substance that looks exactly like the real medicine but contains no active ingredients. It's used to compare the effects of the actual drug.

Who will know if I'm getting the real medicine or the placebo?

In this 'double-blind' study, neither you nor your doctor will know whether you are receiving the new medicine or the placebo until the study is over.

How long will the study last if I join?

The main part of monitoring for the medicine's effect will be for 24 weeks, but overall, your participation and follow-up could last up to 52 weeks.

Can I leave the study at any time?

Yes, your participation is voluntary, and you are free to withdraw from the study at any point, for any reason, without penalty.