Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

This research study is looking for adults aged 18 and over who have high cholesterol. The main goal is to test a new investigational medicine called MK-0616. We want to see how well it lowers 'bad' cholesterol, also known as LDL-C, compared to other commonly used cholesterol-lowering medicines like ezetimibe or bempedoic acid, or even a combination of both. We will carefully compare the new medicine to existing treatments and to a dummy medicine (placebo) to understand its effects. Importantly, we will also be closely monitoring any side effects to make sure the new medicine is safe. The results will help us understand if MK-0616 could be a good new option for managing high cholesterol.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

09 Aug 2024

Hypercholesterolemia

What is this study about?

This study is a really important step in finding new ways to help people manage high cholesterol. High cholesterol can increase your risk of heart problems, so doctors are always looking for better and safer treatments. This particular study is focusing on a new medicine called MK-0616.

Researchers want to see if MK-0616 can effectively lower 'bad' cholesterol (often called LDL-C) and other harmful fats in the blood. They'll be comparing it to some medicines that are already used, like ezetimibe and bempedoic acid. Some participants will also get a dummy medicine, called a placebo. This helps the researchers understand the true effects of the medications being tested. By comparing these different groups, we can get a clear picture of how well and how safely MK-0616 works.

The study will carefully track changes in cholesterol levels over a period of 56 days. They will also keep a close eye on any side effects that people experience. The information gathered will be crucial in deciding if MK-0616 could one day be a new treatment option for people with high cholesterol.

Key takeaways

This study is testing a new medicine (MK-0616) for high cholesterol.
It compares MK-0616 to existing medicines and a dummy pill (placebo).
The main goal is to see how much 'bad' cholesterol (LDL-C) goes down.
Safety and side effects of the new medicine are also being carefully checked.
Participation involves regular clinic visits and taking study medication for about 2 months.

Who may be eligible?

This study is looking for adults who are 18 years old or older. You could be a man or a woman to take part.

Specifically, the study is for people who have high cholesterol. The medical team will check your cholesterol levels and other health information to make sure this study is right for you. There will be some specific medical criteria that determine if you can join, but the main requirement is that you have high cholesterol.

It's important to have a chat with the study doctor or nurse. They can explain all the specific health requirements and make sure you understand if you're a good fit for this research. They'll ask about your health history and any other medicines you're currently taking.

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 told you have high cholesterol?
Are you willing to attend regular clinic appointments for about 2 months?
Are you willing to take study medication as directed?
Are you comfortable with the possibility of receiving a placebo?

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 one of several groups by chance, like flipping a coin. This means you might receive the new medicine (MK-0616), an existing cholesterol medicine (ezetimibe or bempedoic acid, or both), or a dummy medicine called a placebo. You won't know which one you're getting, nor will the study team. This helps ensure the results are fair.

The study will involve regular visits to the clinic over a period of 56 days. During these visits, you'll likely have blood tests to check your cholesterol levels and other health markers. You will also have health checks, and the study team will ask you about any new symptoms or side effects you might be experiencing. You'll be given study medication to take as instructed. After the 56 days, there will be follow-up to make sure you're doing well.

Potential risks and benefits

Participating in a study like this might offer some potential benefits, such as access to a new investigational medicine that could help lower your cholesterol, and close monitoring of your health by a medical team. However, there are also potential risks; you might experience side effects from the study medicine, or the medicine you receive might not improve your cholesterol. As with any medical trial, there's a chance you could receive a placebo and your condition might not change. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
France

Common questions

What is 'high cholesterol'?

High cholesterol means you have too much fatty substance in your blood, which can increase your risk of heart problems. Doctors often call the 'bad' type 'LDL-C'.

What is LDL-C?

LDL-C stands for Low-Density Lipoprotein Cholesterol. It's often called 'bad' cholesterol because high levels can lead to a build-up in your arteries.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real treatment but contains no active ingredients. It helps researchers understand the true effects of the study medicine.

Will I know which medicine I'm getting?

No, you won't know if you're getting the new medicine, an existing medicine, or a placebo. This is called 'double-blind' and helps make the study results more reliable.

How long will I be in the study?

The main part of the study where your cholesterol levels are being closely checked is for 56 days, which is about two months. There will be follow-up after that.