Active not recruitingPHASE3INTERVENTIONAL

Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

This research is an 'extension' study, meaning it follows on from earlier trials. Its main goal is to understand the long-term safety and how well a new medicine, Enlicitide Decanoate, works for adults who have high cholesterol. Participants in this study will be people who have already completed one of three specific earlier studies involving Enlicitide Decanoate. By continuing to monitor these participants, researchers hope to gather more information on the medication's effects over a longer period. This will help them understand its benefits and any potential side effects when used for an extended time. It's an important step in making sure new medicines are both effective and safe for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

3,000

Start

05 Aug 2024

Estimated completion

13 Oct 2028

Hypercholesterolemia

What is this study about?

This study is looking at a new medication called Enlicitide Decanoate, which is being investigated as a possible treatment for high cholesterol. High cholesterol is a common condition where there's too much cholesterol in the blood, which can increase the risk of heart disease and stroke. This particular study is an 'extension' study, which means it builds on information gathered from earlier studies of the same medication.

The main purpose of this extension study is to check the long-term safety and how well Enlicitide Decanoate works over a longer period. Scientists have already run initial studies to see if the medication is effective and safe in the short term. Now, they want to gather more information by observing people for a longer time.

Participants in this study will be adults who have previously taken part in one of three specific studies of Enlicitide Decanoate. By tracking these individuals, researchers can learn more about the medication's effects over an extended period. This kind of research is crucial for understanding how new treatments perform in the real world and ensures that any new medicine is thoroughly tested before it can be widely used.

Key takeaways

This study is testing a new high cholesterol medication called Enlicitide Decanoate.
It's an extension of previous studies, focusing on long-term safety and effectiveness.
Only adults who completed an earlier Enlicitide Decanoate study are eligible.
Participation involves continuing the medication and regular health checks.
The goal is to understand the medication's effects over a longer period.

Who may be eligible?

This study is specifically for adults who have already participated in certain previous studies of Enlicitide Decanoate. To be eligible, you must have completed one of these earlier studies as planned, including all the final checks and procedures.

Also, a key requirement is that you must have taken your study medication at least 80% of the time during your participation in the previous study. This helps ensure that the researchers are studying people who consistently took the medication as directed.

You would not be able to join this study if you stopped taking the study medication in your previous trial, or if you had a serious side effect in the earlier study that your doctor felt was related to the medication and is still ongoing. You also can't be planning to start a different type of cholesterol-lowering medication (called a PCSK9 inhibitor) that's not part of this study, or already be involved in another clinical study that involves a different treatment.

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.

Did you complete one of the previous Enlicitide Decanoate studies (MK-0616-013, -017, or -018)?
Did you take your study medication at least 80% of the time in your previous study?
Are you 18 years old or older?
Are you NOT currently in another treatment-based clinical study?
Are you NOT planning to start a different type of PCSK9 inhibitor medication?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, you would continue to receive the study medication, Enlicitide Decanoate. The study would involve regular visits to a clinic for check-ups. These visits will likely include physical examinations, blood tests to check your cholesterol levels and overall health, and possibly other assessments to monitor your health and how the medication is affecting you. You would be given instructions on how and when to take your medication. The total duration of your participation would depend on the study design, but the goal is to observe the long-term effects of the medication.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit by continuing access to a new medication that could help manage your high cholesterol. However, as with any medication, there's always a possibility of side effects, which could range from mild to more serious. The research team will monitor you closely for any changes in your health. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (222)

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

Alliance for Multispecialty Research, LLC ( Site 0027)
Verified postcode
Daphne, United States
G&L Research ( Site 0035)
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Foley, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)
Verified postcode
Phoenix, United States
National Heart Institute-Research ( Site 0029)
Verified postcode
Beverly Hills, United States
Clinical Trials Research ( Site 0054)
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Sacramento, United States
Velocity Clinical Research, Banning ( Site 0023)
Verified postcode
San Bernardino, United States
Emerson Clinical Research Institute ( Site 0017)
Verified postcode
Washington D.C., United States
Excel Medical Clinical Trials ( Site 0010)
Verified postcode
Boca Raton, United States
Alliance for Multispecialty Research, LLC ( Site 0037)
Verified postcode
Doral, United States
Alliance for Multispecialty Research, LLC ( Site 0056)
Verified postcode
Fort Myers, United States
Velocity Clinical Research, Hallandale Beach ( Site 0053)
Verified postcode
Hallandale, United States
Jacksonville Center for Clinical Research ( Site 0025)
Verified postcode
Jacksonville, United States

Common questions

What is Enlicitide Decanoate?

Enlicitide Decanoate is a new medication being tested to help lower high cholesterol levels in adults.

Why is this called an 'extension' study?

It's an 'extension' study because it follows on from earlier trials of Enlicitide Decanoate, allowing researchers to gather more information over a longer period.

Who can take part in this study?

Only adults who have already completed a specific previous study of Enlicitide Decanoate and have taken the medication consistently can join.

What will happen if I join the study?

You would continue to receive the study medication and attend regular clinic visits for health checks and blood tests.

Can I stop participating if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.