RecruitingPHASE3INTERVENTIONAL

A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)

This research study is looking into a new medication called enlicitide, which is designed to help lower high levels of 'bad' cholesterol, also known as LDL-C. High cholesterol can increase your risk of heart problems. In this study, scientists want to find out how well enlicitide works when given alongside rosuvastatin, a standard medicine already used to treat high cholesterol. They will compare this combination to rosuvastatin with a 'dummy' medicine (placebo) to see if enlicitide makes a significant difference in lowering cholesterol. The aim is to help people aged 18 to 64 who have high cholesterol. Taking part could help improve future treatments for this common health condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

975

Start

11 Nov 2025

Estimated completion

01 Mar 2027

Hyperlipidemia

What is this study about?

This study is investigating a new medication called enlicitide, which has been developed to help reduce levels of 'bad' cholesterol in the blood. This type of cholesterol, known as LDL-C, can build up in your arteries and increase your risk of heart disease and stroke. Scientists want to understand if taking enlicitide together with rosuvastatin, a widely used cholesterol-lowering medicine, is more effective at bringing down LDL-C levels than taking rosuvastatin alone with a 'dummy' pill.

To figure this out, some participants will receive enlicitide and rosuvastatin, while others will get rosuvastatin and a placebo. A placebo looks exactly like the study medicine but doesn't contain any active drug. Comparing the results between these groups helps researchers clearly see if enlicitide is having a real effect. This is a Phase 3 study, meaning it's a large trial that brings us closer to understanding if this new medicine could become a common treatment.

The overall goal is to find better ways to manage high cholesterol. By taking part in this study, you could be contributing important information that might help many people in the future to keep their hearts healthier and reduce their risk of serious health complications associated with high cholesterol.

Key takeaways

This study is testing a new medicine (enlicitide) for high cholesterol.
It checks if enlicitide, combined with a standard medicine (rosuvastatin), lowers 'bad' cholesterol more effectively.
A 'dummy' pill (placebo) is used to help compare results fairly.
Participants must be 18-64 years old with high cholesterol.
Taking part helps advance understanding of cholesterol treatments.

Who may be eligible?

To join this study, you need to be an adult between 18 and 64 years old with high cholesterol. You should either not be taking any cholesterol-lowering medicines yet, or have stopped certain ones a while ago before the study starts. You also need to be willing to take a statin medicine if you're not already, as part of the study.

However, there are some reasons why you might not be able to join. For example, if you have a rare, very specific type of inherited high cholesterol (known as homozygous, compound heterozygous, or double heterozygous familial hypercholesterolemia), or if you've been in hospital for heart failure recently. Also, if you’ve had serious muscle problems from statins before, or other specific muscle or nerve conditions, or if you have a severe liver problem or HIV, this study might not be right for you.

Finally, if you're undergoing a special blood filtering treatment for cholesterol (LDL-C apheresis) or taking medicines that might react badly with rosuvastatin, you won't be able to participate. The study team will check all these details carefully to make sure it's safe and suitable for you to take part.

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 between 18 and 64 years old?
Do you have high cholesterol?
Have you recently stopped taking or not yet started cholesterol-lowering medicines?
Have you *not* been in hospital for heart failure recently (last 3 months)?
Have you *not* had severe muscle problems with statin medicines before?
Do you *not* have a severe liver condition or HIV?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be part of a group that helps researchers understand how a new medicine works. You would be given either the new medicine (enlicitide) along with a standard cholesterol medicine (rosuvastatin), or rosuvastatin with a 'dummy' pill. You wouldn't know which one you are receiving.

Your participation would involve regular visits to a clinic. During these visits, the study team would check your health, take blood samples to measure your cholesterol levels, and ask you questions about how you are feeling. You would also need to take the study medicines as instructed. The total length of your participation in the study, including all visits and follow-up, would be fully explained to you before you agree to take part.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as contributing to scientific understanding of a new cholesterol treatment and receiving close medical monitoring. However, there are also potential risks; you might experience side effects from the study medicines, or the treatment might not work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (89)

Central Research Associates ( Site 0009)
Verified postcode
Birmingham, United States· Recruiting
G&L Research ( Site 0024)
Verified postcode
Foley, United States· Recruiting
Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
Verified postcode
Phoenix, United States· Active not recruiting
Alliance for Multispecialty Research LLC ( Site 0049)
Verified postcode
Tempe, United States· Active not recruiting
Chemidox Clinical Trials ( Site 0008)
Verified postcode
Lancaster, United States· Recruiting
Clinical Trials Research ( Site 0036)
Verified postcode
Sacramento, United States· Recruiting
Legacy Clinical Trials ( Site 0044)
Verified postcode
Colorado Springs, United States· Recruiting
Alliance for Multispecialty Research, LLC ( Site 0040)
Verified postcode
Fort Myers, United States· Active not recruiting
Soffer Health Institute ( Site 0046)
Verified postcode
Hollywood, United States· Recruiting
East Coast Institute for Research ( Site 0041)
Verified postcode
Lake City, United States· Active not recruiting
Inpatient Research Clinic ( Site 0017)
Verified postcode
Miami Lakes, United States· Active not recruiting
Clinical Research Trials of Florida ( Site 0001)
Verified postcode
Tampa, United States· Active not recruiting

Common questions

What is 'bad cholesterol'?

'Bad cholesterol' is usually short for LDL-C. High levels of it can build up in your blood vessels and increase your risk of heart problems.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers compare results more accurately.

Will I know if I'm getting the new medicine?

No, in this study, neither you nor your study doctor will know whether you are receiving the new medicine or the placebo. This is called 'blinding' and helps keep the study fair.

What is rosuvastatin?

Rosuvastatin is a common medicine (a type of statin) that doctors prescribe to help lower high cholesterol levels in the blood.

Can I stop participating at any time?

Yes, you have the right to withdraw from the study at any point, for any reason, without needing to explain why, and it will not affect your future medical care.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.