Active not recruitingPHASE3INTERVENTIONAL

Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

This research study is investigating a new medication called Obicetrapib. It's for people who have a condition called atherosclerotic cardiovascular disease (a type of heart disease where arteries narrow due to plaque buildup). Despite already being on the best available cholesterol-lowering treatments, these individuals may still be at risk. The study will compare Obicetrapib to a 'dummy' pill (placebo) to see if it can help lower the chances of significant heart-related events such as heart attacks, strokes, and the need for heart procedures. This is a Phase 3 study, meaning it's a large trial to confirm the medicine's effectiveness and safety before it could potentially become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

NewAmsterdam Pharma

Enrolment target

9,541

Start

07 Feb 2022

Estimated completion

01 Nov 2026

Atherosclerotic Cardiovascular Disease

What is this study about?

This important research study, called the PREVAIL Study, is designed to understand if a new medicine, Obicetrapib, can help people with a condition called atherosclerotic cardiovascular disease (ASCVD). This is a common type of heart disease where fatty deposits, known as plaque, build up in your arteries, making them narrower and harder. This can lead to serious problems like heart attacks and strokes. Many people with ASCVD take medicines to lower their cholesterol, but even with the best treatments, some individuals might still be at risk.

The main goal of this study is to see if Obicetrapib can reduce the risk of future heart problems. This includes events like having a heart attack, suffering a stroke, dying from heart-related causes, or needing a procedure to open up blocked heart blood vessels. The study will involve a large number of people to get a clear picture of how effective and safe Obicetrapib might be.

Participants will be given either Obicetrapib or a 'dummy' pill (called a placebo). Neither the participants nor their doctors will know who is getting which, to ensure the results are as unbiased as possible. This approach allows researchers to accurately compare the effects of the new medicine against not receiving the active treatment. If successful, Obicetrapib could offer a new treatment option for people living with ASCVD.

Key takeaways

This study investigates a new medicine, Obicetrapib, for heart disease.
It aims to reduce heart attacks, strokes, and related procedures.
Participants must have existing heart disease and cholesterol not fully controlled by current treatments.
You might receive the active drug or a 'dummy' pill (placebo).
Close monitoring and support will be provided during the study.
You can stop participating at any time.

Who may be eligible?

To join this study, participants must be at least 18 years old, male or female, and have atherosclerotic cardiovascular disease (ASCVD). This includes conditions like coronary artery disease (heart artery problems), cerebrovascular disease (brain blood vessel problems), or peripheral artery disease (leg blood vessel problems). You would also need to be already taking the highest dose of cholesterol-lowering medication you can tolerate, but your 'bad' cholesterol (LDL-C) would still be above a certain level.

There are also some health conditions that would prevent someone from joining. For example, if you have severe heart failure, have been hospitalised for heart failure recently, or had a heart attack or stroke in the last three months, you wouldn't be able to participate. Uncontrolled high blood pressure, certain liver or kidney issues, or uncontrolled diabetes could also exclude you.

Other reasons you might not be eligible include having certain thyroid conditions, a recent history of cancer or substance abuse, or if you've recently taken part in another research study involving a new medicine or device. It's really important to discuss your full medical history with the study team to see if this study is right for you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with coronary artery disease, cerebrovascular disease, or peripheral artery disease?
Are you currently taking the strongest cholesterol-lowering treatment you can tolerate, but your 'bad' cholesterol (LDL-C) is still above a certain level?
Have you *not* had a heart attack, stroke, or surgery to unblock heart arteries in the last 3 months?
Do you *not* have severe heart failure or uncontrolled high blood pressure?
Are you *not* pregnant or breastfeeding (if applicable)?

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 in this study, you would first go through a screening process to check if you meet all the requirements. If eligible, you would be randomly assigned to receive either the study drug, Obicetrapib, or a placebo (a tablet that looks the same but contains no active medicine). You wouldn't know which one you're getting, and neither would your study doctor. This is to ensure the results are fair.

The study will involve regular visits to the clinic for health checks, blood tests, and to collect your study medication. These visits will help the research team monitor your health, how you're reacting to the medication, and to see if your condition is improving. The exact number and frequency of visits, as well as the total length of your participation in the study, would be fully explained by the study team. You would receive support and monitoring throughout your time in the study.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of joining this study is that you might receive access to a new medicine, Obicetrapib, which could help lower your risk of serious heart problems. However, it's also possible you could receive the placebo and not the active drug. There is also no guarantee that Obicetrapib will work for you, or that it will be better than your current treatment. Potential risks could include side effects from the medication. All possible side effects would be fully explained before you join. Your safety is a top priority, and you would be closely monitored by the study team. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (591)

Advanced Cardiovascular LLC
Alexander City, United States
Ascension - Cardiology Specialists of Birmingham
Birmingham, United States
Central Alabama Research
Birmingham, United States
Cardiovascular Associates of the Southeast, LLC
Birmingham, United States
Eastern Shore Research Institute, LLC
Fairhope, United States
The Heart Center Research
Huntsville, United States
Mobile Heart Specialists
Mobile, United States
Syed Research Consultants
Muscle Shoals, United States
Syed Research Consultants
Sheffield, United States
Elite Clinical Studies
Phoenix, United States
Clinical Research Institute of Arizona, LLC
Sun City West, United States
Eclipse Clinical Research
Tucson, United States

+579 more sites — see the official record for the full list.

Common questions

What is 'atherosclerotic cardiovascular disease'?

It's a common type of heart disease where fatty plaque builds up in your arteries, making them narrower. This can lead to heart attacks and strokes.

What does 'maximally tolerated lipid-lowering therapy' mean?

It means you're already taking the highest dose of cholesterol-lowering medication (like statins) that you can without uncomfortable side effects.

What is a 'placebo'?

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

Why don't I know if I'm getting the drug or the placebo?

This is called 'double-blind' and it helps make sure the study results are fair and unbiased. Neither you nor your doctor will know, so expectations don't affect how you feel or how your doctor assesses you.

Can I stop participating in the study at any time?

Yes, absolutely. Your participation is completely voluntary, and you can withdraw from the study at any point, for any reason, without it affecting your medical care.