Active not recruitingPHASE3INTERVENTIONAL

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

This important study, called CORALreef Outcomes, is checking a new daily tablet called enlicitide decanoate. It's for adults (aged 18 and over) who are at high risk of serious heart and blood vessel problems, such as a heart attack or stroke. The pill works differently to existing medicines. Researchers want to find out if this new medicine can help prevent these serious events and if it's safe to use. Half the people in the study will take the new pill, and the other half will take a dummy pill (placebo). This is to properly compare how well the new medicine works against not having the active medicine, alongside their usual care.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

14,550

Start

09 Oct 2023

Estimated completion

29 Nov 2031

Arteriosclerosis Hypercholesterolaemia

What is this study about?

This study, called CORALreef Outcomes, is testing a new daily tablet called enlicitide decanoate. It's designed for people who have already had serious heart issues, like a heart attack or stroke, or who are at a high risk of having them in the future. The new pill works in a unique way in the body to help manage cholesterol, which is a key factor in heart and blood vessel disease.

Heart and blood vessel diseases are very common in the UK and can lead to serious health problems. Current treatments work well, but doctors are always looking for new and better ways to prevent these life-threatening events. This study hopes to show if enlicitide decanoate can be a new option to help reduce the chances of these serious events happening, such as another heart attack, stroke, or severe problems with blood flow to the legs, and to see if it's safe.

The study is in its final stage, known as Phase 3. This means it has already been tested in smaller groups of people and now needs to be studied in a much larger group to confirm its effectiveness and safety before it could potentially be made available to everyone. Participants will be randomly assigned to receive either the new drug or a dummy pill, alongside their usual cholesterol-lowering medicines, to get a clear comparison.

Key takeaways

Tests a new daily pill, enlicitide decanoate, for heart health.
Aims to prevent heart attacks, strokes, and similar serious events.
Compares the new pill to a dummy pill (placebo).
Targets adults at high risk of heart and blood vessel problems.
Requires stable use of current cholesterol medicines.
Involves regular clinic visits and health checks.

Who may be eligible?

To join this study, you generally need to be at least 18 years old and have a high risk of heart and blood vessel problems. This means you might have already had a heart attack, stroke, or a procedure to improve blood flow in your legs. Alternatively, you could be considered high-risk if you're over 50 with signs of heart, brain, or leg circulation problems, or over 60 with diabetes that’s been present for a while or is more difficult to control.

Another important point is about your cholesterol levels. Even if you're taking cholesterol-lowering medicines like statins, your 'bad' cholesterol (LDL-C) or non-HDL cholesterol would still need to be above a certain level when measured at the start of the study. You also need to be on a stable dose of your current cholesterol medicines for at least a month before joining, and not planning to change them during the study. Unfortunately, you wouldn't be able to join if you have a specific genetic type of very high cholesterol called homozygous familial hypercholesterolemia, or if you have very severe heart failure.

Quick self-check

Are you 18 or older?
Have you had a heart attack, stroke, or certain leg circulation procedures?
Or are you over 50 with other heart/blood vessel issues, or over 60 with diabetes?
Are you currently taking statins or other cholesterol medicines?
Are your cholesterol levels still above a certain point, even with medicine?
Do you *not* have very severe heart failure or a specific genetic cholesterol condition?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive the new study drug (enlicitide decanoate) or a dummy pill (placebo) every day. You'll continue taking your usual cholesterol-lowering medicines as prescribed by your doctor. The study will involve several visits to the clinic, where the study team will carry out health checks, take blood samples, and ask about your health. These visits will allow the researchers to monitor your health, check how your body is reacting to the treatment, and see if the medication is helping to lower your cholesterol and prevent heart problems. The study will run for an extended period, potentially several years, to fully assess the drug's long-term effects and safety. You will have regular contact with the study team throughout this time.

Potential risks and benefits

Taking part in a clinical trial has potential benefits, such as receiving a new treatment that might improve your health and contributing to medical knowledge that could help others. However, there are also potential risks, including side effects from the study drug, or that the drug may not work for you. The dummy pill has no active ingredients so won't have drug-related side effects, but you'll still have clinic visits and tests. You will be closely monitored, and any concerns you have will be addressed by the research team. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (669)

Advanced Cardiovascular - Alexander City ( Site 0156)
Alexander City, United States
Central Research Associates ( Site 0118)
Birmingham, United States
St. Vincent's Birmingham Hospital ( Site 0181)
Birmingham, United States
Central Alabama Research ( Site 0109)
Birmingham, United States
Alliance for Multispecialty Research, LLC ( Site 0076)
Daphne, United States
G&L Research ( Site 0042)
Foley, United States
NextStage Clinical Research - Phoenix - (01) ( Site 0191)
Glendale, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0066)
Phoenix, United States
Medical Investigations Inc. ( Site 0188)
Little Rock, United States
National Heart Institute-Research ( Site 0077)
Beverly Hills, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0130)
La Jolla, United States
Chemidox Clinical Trials ( Site 0145)
Lancaster, United States

+657 more sites — see the official record for the full list.

Common questions

What is the main goal of this study?

The main goal is to see if the new daily pill, enlicitide decanoate, can safely reduce the risk of serious heart events like heart attacks and strokes in people at high risk.

What is a 'dummy pill'?

A dummy pill, or placebo, looks exactly like the study drug but contains no active medicine. It helps researchers compare the new drug's effects accurately.

How long will I be in the study?

The study will run for several years to ensure we can properly evaluate the long-term effects and safety of the new medicine.

Can I still take my regular medication?

Yes, you will continue your usual cholesterol-lowering medications, like statins, throughout the study. The new pill would be in addition to these.

What does 'high cardiovascular risk' mean?

It means you have a higher chance of developing serious heart and blood vessel problems, often due to a history of heart attack, stroke, or other factors like diabetes or existing circulation issues.