RecruitingPHASE3INTERVENTIONAL

Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days

This research is looking into two different medicines, obicetrapib and bempedoic acid, to see which is better at lowering 'bad' cholesterol (LDL-C). It involves adults who have high cholesterol or a condition called mixed dyslipidemia. These are people who are already taking cholesterol-lowering treatments but still have high LDL-C and are at a higher risk of heart and blood vessel problems. The study will compare how much each medicine can bring down LDL-C levels over about 12 weeks. Researchers will also be checking for any side effects to make sure the medicines are safe and well-tolerated. This is a Phase 3 study, meaning it’s one of the final steps before a medicine might become available for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

A. Menarini International Licensing S.A.

Enrolment target

426

Start

06 May 2026

Estimated completion

01 Jan 2027

Mixed Dyslipidemia Hypercholesterolaemia

What is this study about?

This study is looking at two medicines, obicetrapib and bempedoic acid, to understand how well they can lower 'bad' cholesterol, also known as LDL-C. Lowering LDL-C is important because high levels can increase your risk of heart attacks and strokes. The people taking part in this study already have high cholesterol (hypercholesterolemia) or mixed dyslipidemia, which means they have both high cholesterol and other unhealthy fats in their blood. Even though they are already receiving regular cholesterol-lowering treatment, their LDL-C levels are still higher than they should be, and they are considered to be at a higher risk of heart disease.

The main goal is to compare obicetrapib with bempedoic acid to see which one is more effective at reducing LDL-C after about 12 weeks of treatment. This is a 'Phase 3' study, which means it's a large and important step in the development of new medicines. It helps researchers gather detailed information on how well the medicines work and if they are safe for people to use.

By taking part, individuals are contributing to important research that could lead to new ways of managing cholesterol for people who are struggling to get their levels down. The study is designed to be fair, with participants randomly assigned to receive one of the two medicines, and neither the participants nor the doctors will know which medicine is being given until the study is over. This is called a 'double-blind' study and helps ensure the results are as accurate as possible.

Key takeaways

This study compares two medicines for lowering 'bad' cholesterol (LDL-C).
It's for adults with high cholesterol or mixed dyslipidemia whose LDL-C remains high despite current treatments.
The study assesses how well the medicines work and if they are safe.
Participants will be part of a 'double-blind' trial, meaning treatment is assigned randomly and kept secret.
It lasts for about 12 weeks and involves several clinic visits for checks and blood tests.

Who may be eligible?

This study is looking for adults who are 18 years or older, both men and women. Women who are pregnant, breastfeeding, or planning to become pregnant are not able to join. You should have high cholesterol or mixed dyslipidemia that isn't caused by a specific genetic condition (non-familial hypercholesterolemia) and be at a high risk of heart problems. You must already be on a stable dose of cholesterol-lowering medicine, like a statin, and possibly other treatments, for at least 8 weeks, but your 'bad' cholesterol (LDL-C) levels are still too high (between 1.81 mmol/L and 3.37 mmol/L). Your other blood fats called triglycerides should also be below a certain level.

There are also some reasons why you might not be able to join. For example, if you have severe heart failure, have been in hospital for heart failure recently, or have had a heart attack or stroke within the last 3 months, you wouldn't be able to participate. You also can't join if you have uncontrolled very high blood pressure, a specific genetic form of high cholesterol (familial hypercholesterolemia), active liver disease, or very high blood sugar levels. They will also check your kidney function to make sure it's healthy enough for the study.

Quick self-check

Are you 18 years or older?
Do you have high cholesterol or mixed dyslipidemia?
Are you already taking cholesterol-lowering medicines but your 'bad' cholesterol (LDL-C) is still high?
Are you generally in good health, without severe heart failure or recent major heart events?
Are you female and not pregnant, breastfeeding, or planning to become pregnant?

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

What does participation involve?

If you take part in this study, it will last for about 84 days, which is roughly 12 weeks. You will be provided with either obicetrapib or bempedoic acid (which could be a dummy pill for one of the medicines, as it's a 'double-blind' study). You will have several clinic visits where doctors will check your general health, measure your cholesterol levels, and look for any side effects. These visits will involve blood tests to track your cholesterol and other health markers. You will continue to take your regular cholesterol-lowering medicines throughout the study. The study team will guide you through each step and answer any questions you have.

Potential risks and benefits

Taking part in a clinical study means you might receive a medicine that could help lower your cholesterol more effectively than your current treatment. However, there's also a chance that the medicine might not work for you, or you might experience side effects. All possible side effects will be carefully monitored by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care. The specific risks will be fully explained to you before you decide to join.

Locations (1)

FutureMeds North Tees
Stockton-on-Tees, United Kingdom· Recruiting

Common questions

What is 'bad' cholesterol (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, increasing your risk of heart disease.

What is 'Phase 3' in a clinical study?

Phase 3 is a late stage of clinical research where a new medicine is tested on a large group of people to confirm its effectiveness, monitor side effects, compare it to common treatments, and collect information that will allow the medicine to be used safely.

Will I know which medicine I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know whether you are receiving obicetrapib or bempedoic acid (or a placebo for one of them). This helps ensure the study results are fair and unbiased.

Can I stop taking my other cholesterol medicines?

No, you must continue taking your current cholesterol-lowering medicines as prescribed by your doctor throughout the study. This study is testing new medicines alongside your existing treatment.

What does 'at high or very high cardiovascular risk' mean?

This means you have existing conditions or risk factors that make you more likely to have heart attacks, strokes, or other heart and blood vessel problems.

How to find out more

Andrea Conte, Medical Doctor

aconte@menarini.lu +352 26497650 Official trial record

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