Muvalaplin to lower major heart and stroke events in adults with high lipoprotein(a)

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

Phase 3 Interventional Eli Lilly and Company · NCT07157774

This study tests whether muvalaplin can lower the chance of heart attack, stroke, or other major cardiovascular events in adults with high lipoprotein(a) who have or are at risk for cardiovascular disease.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment10450 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations754 sites (Gilbert, Arizona and 753 other locations)
Trial IDNCT07157774 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized, placebo-controlled trial will enroll adults with Lp(a) ≥175 nmol/L who either have had an ASCVD event within the past 10 years or are at high risk for a first event. Participants will be randomized to receive muvalaplin or placebo and followed with regular visits to track major cardiovascular events and safety. The primary comparison is the rate of major adverse cardiovascular events between the muvalaplin and placebo groups over the follow-up period. Eli Lilly is sponsoring the multicenter trial with enrollment at several clinical sites in Arizona.

Who should consider this trial

Good fit: Adults with Lp(a) ≥175 nmol/L who have had an ASCVD event within the last 10 years or who have high-risk features for a first event (such as documented CAD, carotid stenosis, PAD, a high coronary artery calcium score, or diabetes with reduced kidney function) are ideal candidates.

Not a fit: People with Lp(a) below 175 nmol/L, those who had a major cardiovascular event or surgery within 90 days, or those planning such procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, muvalaplin could reduce heart attacks, strokes, and other major cardiovascular events in people with elevated Lp(a).

How similar studies have performed: Other Lp(a)-lowering therapies have produced large Lp(a) reductions, but proof that lowering Lp(a) reduces heart attacks and strokes is not yet established, making this phase 3 outcome trial important.

Eligibility criteria

Show full inclusion / exclusion criteria
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

Where this trial is running

Gilbert, Arizona and 753 other locations

+704 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Elevated LpAtherosclerotic Cardiovascular Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.