Muvalaplin for Elevated Lipoprotein(a) and Cardiovascular Risk

This study is testing a drug called muvalaplin to see if it can reduce the risk of serious heart problems like heart attack or stroke in adults. You may be able to join if you have high levels of lipoprotein(a) (Lp(a) ≥175 nmol/L) and have already had a heart attack, stroke, or procedure to restore blood flow, or if you are at risk for these events. Participants will receive either muvalaplin or a placebo (an inactive substance) given by mouth. The main goal is to see if muvalaplin can prevent the first occurrence of major heart-related events over about 5.25 years. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 10,450 participants. Participants will receive either muvalaplin or a placebo orally.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from baseline up to the end of the study, which is about 5.25 years, to track major adverse cardiac events.

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NCT07157774

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Eli Lilly and Company
~10,450 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:MuvalaplinPlacebo

At a glance

Recruiting sites
703 of 801 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
Measured over Baseline up to End of Study (About 5.25 Years)
Elevated Lp(a)
Atherosclerotic Cardiovascular Disease (ASCVD)
801 sites across 62 states
Japan64
Argentina55
China49
Mexico48
Spain43
Brazil38
Germany37
Australia27
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Eligibility criteria

Inclusion

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

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
  • Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite EndpointBaseline up to End of Study (About 5.25 Years)

    Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.