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A study to evaluate the effect of muvalaplin on reducing major cardiovascular events in adults with high levels of lipoprotein(a) and atherosclerotic cardiovascular disease.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with high levels of Lipoprotein(a), which is a type of fatty particle in the blood that can increase the risk of heart issues. The research also involves people living with Atherosclerotic Cardiovascular Disease, a condition where plaque builds up in the arteries, potentially leading to serious health problems. The purpose of this study is to evaluate whether the drug muvalaplin can help reduce the occurrence of Major Adverse Cardiovascular Events, which are serious heart-related problems such as heart attacks or strokes.

Participants in the study will be assigned to receive either muvalaplin, which is taken as an oral tablet, or a placebo. This is a randomized study, meaning the treatment assigned is determined by chance, and it is double-blind, so neither the participants nor the researchers know which treatment is being given during the trial. The study will monitor how the medication affects the risk of experiencing major heart events over time.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    You will receive either the test medication, called muvalaplin, or a placebo, which is a substance that looks like the medicine but contains no active ingredients.

    The muvalaplin is taken in the form of a tablet by oral use (swallowing).

  2. Step 2

    <b>monitoring for cardiovascular events</b>

    The study aims to observe the effect of the medication on reducing major adverse cardiovascular events. these are serious health issues related to the heart or blood vessels.

    The focus is on monitoring for atherosclerotic cardiovascular disease, which is a condition where plaque (a fatty buildup) narrows the arteries, and for individuals with elevated lipoprotein(a), a specific type of protein found in the blood.

Who can join the trial?

6 criteria

  • You must have high levels of Lp(a), which is a specific type of protein in your blood that can contribute to heart problems, with a level of 175 nmol/L or more.
  • You must have experienced a previous heart-related event, such as a heart attack (when blood flow to the heart is blocked), a stroke (when blood flow to the brain is blocked), or have had a procedure to improve blood flow to your heart or other parts of your body.
  • Alternatively, you may qualify if you are at risk for your first heart event and have coronary artery disease (narrowing of the arteries that supply blood to the heart), carotid stenosis (narrowing of the arteries in the neck that lead to the brain), or peripheral artery disease (narrowing of the blood vessels that carry blood to the legs or arms).
  • You may also qualify if you have a high coronary artery calcium score, which is a measurement used to check for calcium buildup in the arteries of the heart.
  • You may also qualify if you have reduced kidney function (your kidneys are not filtering blood as well as they should) and also have diabetes.
  • You may also qualify if you have a combination of other high-risk factors that increase the chance of heart problems.

Who cannot join the trial?

6 criteria

  • You cannot participate if you have had a major heart or blood vessel event, which is a serious medical emergency involving the heart or the tubes that carry blood, within 90 days before starting the study.
  • You cannot participate if you are planning to have any surgery on your heart or your arteries, which are the blood vessels that carry oxygen-rich blood away from the heart.
  • You cannot participate if you have very high blood pressure or serious heart failure, a condition where the heart cannot pump blood effectively enough to meet the body's needs.
  • You cannot participate if you have had or are planning to have a procedure to remove cholesterol from the blood within 90 days before starting the study.
  • You cannot participate if you have severe kidney failure, which means your kidneys are not working well enough to filter waste from your blood.
  • You cannot participate if you have a history of cancer, meaning you have been diagnosed with or treated for cancer, within 5 years before starting the study.
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Investigated drugs

Muvalaplin is a medication taken by mouth that is being tested to see if it can help reduce the risk of serious heart problems, such as heart attacks or strokes, in adults who have high levels of a specific type of protein in their blood called lipoprotein(a).

What is already known about the treatment

  • Placebo to match LY

    This is an inactive substance given by mouth in the same form as the study medication to ensure the trial remains fair and unbiased. It contains no active ingredients and is used as a control to compare against the actual treatment. In clinical studies, it serves as a baseline to help researchers determine if the effects seen in patients are truly caused by the experimental drug.

  • Muvalaplin

    This medication is an oral tablet used to study the reduction of risks associated with high levels of a specific fat in the blood called lipoprotein(a). Currently being investigated in late-stage clinical trials, it belongs to a class of drugs designed to lower these specific fats to prevent heart attacks and strokes. It works at a molecular level by interfering with the body's ability to produce and release these harmful particles into the bloodstream.

Investigated diseases

  • Elevated Lp(a)

    This condition occurs when there is an unusually high level of Lipoprotein(a) in the blood. This substance is a type of particle that carries cholesterol through the bloodstream. Over time, high levels can contribute to the buildup of fatty deposits within the artery walls. This process can narrow the passages through which blood flows. The condition is often determined by genetic factors rather than lifestyle alone.

  • Atherosclerotic Cardiovascular Disease

    This condition involves the buildup of fats, cholesterol, and other substances in and along the artery walls. This buildup is known as plaque. As the plaque grows, it can cause the arteries to become narrow and hard. This narrowing restricts the flow of oxygen-rich blood to various parts of the body. The condition typically progresses slowly over many years.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521067-13-00Protocol codeJ2O-MC-EKBGEstimated enrolment10 450 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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