A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(A) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event

Study on Investigational Medication for Cardiovascular Events in Adults with High Lipoprotein(A)

J
Julie Clary, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase 3
13 participants needed
1 Location

Brief description of study

Elevated lipoprotein(a) (Lp[a]) is recognized as an important risk factor for cardiovascular disease. However, there are currently no approved pharmaceutical interventions for Lp(a) lowering. Recent studies have demonstrated that muvalaplin effectively reduces Lp(a) and is well tolerated by study participants. This study will investigate the effect of muvalaplin on the reduction of major adverse cardiovascular events in adults with elevated Lp(a) who have either a prior atherosclerotic cardiovascular disease (ASCVD) event or are at risk for a first ASCVD event. This study will also provide additional evidence for the potential clinical benefits of muvalaplin in this population.The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.

THIS STUDY IS ENROLLING BY INVITATION ONLY 

Detailed description of study

Study J2O-MC-EKBG is a Phase 3, global, randomized, double-blind, placebo-controlled, parallel-group, event-driven study to investigate the reduction of MACE with muvalaplin treatment compared to placebo in adult participants with elevated Lp(a) and a prior ASCVD event or at risk for a first ASCVD event.
This study includes:
 an optional prescreening visit
 a screening period
 a treatment and assessment period, and
 a final visit.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atherosclerotic Cardiovascular Disease (ASCVD), Elevated Lipoprotein Lp(a)
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:

  • Have Lp(a) ≥175 nanomoles per liter (nmol/L)
  • Meet one of the following criteria:
    • Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 years prior to screening
    • Are at risk for a first ASCVD event, defined as one or more of the following:
      • Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a history of ASCVD event
      • A high coronary artery calcium (CAC) score
      • Reduced kidney function with diabetes
      • Combination(s) of high risk factors

Exclusion Criteria:

  • Have experienced a major cardiovascular event or surgery, such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body, within 90 days prior to screening or occurring between screening and randomization
  • Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study
  • Have uncontrolled high blood pressure
  • Have New York Heart Association (NYHA) class III or IV heart failure
  • Have undergone a procedure to remove cholesterol from the blood within 90 days of screening, or have a planned procedure during the study
  • Have severe kidney impairment
  • Have had cancer within 5 years prior to screening

This study investigates the effect of an investigational medication on reducing major adverse cardiovascular events in adults with high levels of lipoprotein(a), a substance in the blood linked to heart disease. People with high lipoprotein(a) may have had a heart attack, stroke, or other heart-related issues, or be at risk for these problems. The purpose of this study is to see if the investigational medication can lower the chance of having these serious heart events.

Participants will go through several steps, including an optional prescreening visit, a screening period, a treatment and assessment period, and a final visit. In this study, participants will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will compare the outcomes between these two study arms.

  • Who can participate: Adults with lipoprotein(a) levels of 175 nmol/L or higher who have had a prior atherosclerotic cardiovascular event within the last 10 years, or who are at risk for a first event due to conditions like coronary artery disease or high coronary artery calcium score, may participate. Exclusions include recent major cardiovascular events, planned major surgeries, uncontrolled high blood pressure, severe kidney issues, or recent cancer.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
Updated on 20 May 2026. Study ID: BLOOM-LILLY-MOVE-LPA, 30984, ECRO-LILLY-MOVE-LPA, 30812
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only