RecruitingPHASE3INTERVENTIONAL

Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)

This research study is investigating a new medication called muvalaplin. It aims to find out if muvalaplin can effectively reduce the chances of serious heart problems, like heart attacks and strokes, in adults. Participants in the study have naturally high levels of a substance in their blood called lipoprotein(a), often shortened to Lp(a). High Lp(a) can increase the risk of heart and blood vessel disease. The study will compare muvalaplin against a placebo (a dummy pill) to understand its impact on heart health for people who either already have heart disease or are considered to be at a higher risk of developing it. This type of research helps doctors find better ways to protect people from heart and stroke conditions.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

10,450

Start

02 Sep 2025

Estimated completion

01 Mar 2031

Elevated Lp(a)Atherosclerotic Cardiovascular Disease (ASCVD)

What is this study about?

This study is looking into a new medicine called muvalaplin. The main goal is to see if this medicine can help reduce the number of heart attacks, strokes, and other serious heart-related problems in adults. The people joining this study all have something called high lipoprotein(a), often called Lp(a) for short. Lp(a) is a type of fat in your blood that can increase your risk of heart disease, even if your other cholesterol levels are normal.

Heart and blood vessel disease (doctors call this Atherosclerotic Cardiovascular Disease or ASCVD) is a common and serious health issue. It can lead to heart attacks, strokes, and problems with blood flow to other parts of the body. Finding new ways to lower the risk of these events is very important for many people.

By comparing muvalaplin to a placebo (a pill with no medicine in it), researchers can accurately tell if muvalaplin is effective. The results will help doctors understand if this new medicine could be a useful treatment to protect people who have high Lp(a) and are at risk of heart problems.

Key takeaways

The study tests a new medicine, muvalaplin, to reduce heart attack and stroke risk.
It's for adults with high Lp(a), a type of blood fat.
Participants either have existing heart disease or are at high risk.
The study compares muvalaplin to a placebo (dummy pill).
Participation involves regular clinic visits for checks and tests.
Your health will be closely monitored throughout.

Who may be eligible?

To join this study, adults need to have high levels of Lp(a) in their blood. This means your Lp(a) level must be at least 175 nanomoles per liter. Additionally, you must either have had a heart attack, stroke, or a procedure to help blood flow in your heart or other arteries within the last 10 years, or be at a high risk of having one of these events for the first time.

Being at high risk might mean you have conditions like narrowed arteries (in your heart, neck, or legs), or certain combinations of risk factors. Your doctor will help determine if you fit these criteria.

Some things would mean you can't join the study. For example, if you've had a recent heart attack, stroke, or surgery in the last three months, or if you're planning such a procedure soon. You also can't take part if you have very high blood pressure that's not controlled, severe heart failure, serious kidney problems, or have had cancer in the last five years.

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.

Do I have high Lp(a) levels (175 nmol/L or higher)?
Have I had a heart attack, stroke, or heart procedure within the last 10 years, OR am I at high risk for one?
Have I avoiding a major heart event or surgery in the last 3 months?
Do I have well-controlled blood pressure?
Do I have healthy kidney function (or mild kidney issues, but not severe)?
Have I been free of cancer for the last 5 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll either receive the study medicine, muvalaplin, or a placebo (a dummy pill, which looks the same but contains no active medicine). You won't know which one you're taking, nor will your study doctor. This is standard practice in clinical trials and helps ensure fair results. You will have regular visits to the clinic for health checks, blood tests, and to review how you are feeling. These visits will help the study team monitor your health and how the medicine is affecting you. The total duration of your participation in the study, including all follow-up, will be decided by the researchers. All procedures, tests, and medications directly related to the study will be provided at no cost to you.

Potential risks and benefits

Participating in this study might offer the potential benefit of reducing your risk of heart attacks and strokes, or contributing valuable information that could help others in the future. However, there are also potential risks, including side effects from the study medication or discomfort from tests like blood draws. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. The study team will discuss all potential risks and benefits with you in detail before you make a decision.

Locations (752)

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

Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Verified postcode
Gilbert, United States· Recruiting
Axsendo Clinical Research - Peak Heart & Vascular - Phoenix
Verified postcode
Phoenix, United States· Recruiting
Clinical Research Institute of Arizona (CRI) - Sun City West
Verified postcode
Sun City West, United States· Recruiting
Southwest Kidney Institute - Surprise
Verified postcode
Surprise, United States· Recruiting
Pima Heart
Verified postcode
Tucson, United States· Recruiting
National Heart Institute
Verified postcode
Beverly Hills, United States· Recruiting
John Muir Medical Center - Concord Campus
Verified postcode
Concord, United States· Recruiting
Neighborhood Healthcare Institute of Health
Verified postcode
Escondido, United States· Recruiting
Ark Clinical Research - Fountain Valley
Verified postcode
Fountain Valley, United States· Recruiting
Care Access - Huntington Beach
Verified postcode
Huntington Beach, United States· Recruiting
The Cardiovascular Center
Verified postcode
Redding, United States· Recruiting
UCLA South Bay Endocrinology
Verified postcode
Torrance, United States· Recruiting

Common questions

What is Lp(a)?

Lp(a) (lipoprotein(a)) is a type of fat and protein in your blood that, when high, can increase your risk of heart disease and stroke.

What does 'placebo' mean?

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

Will I have to pay to be in the study?

No, all study-related treatments, tests, and doctor visits are provided free of charge.

How long will the study last for me?

The total length of your participation, including follow-up appointments, will be explained by the study team. It will involve regular visits over a period of time.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

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