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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
  Gilbert, Arizona, United States Recruiting
• Onyx Clinical Research
  Phoenix, Arizona, United States Recruiting
• Clinical Research Institute of Arizona (CRI) - Sun City West
  Sun City West, Arizona, United States Recruiting
• Southwest Kidney Institute - Surprise
  Surprise, Arizona, United States Recruiting
• Pima Heart
  Tucson, Arizona, United States Recruiting
• Eclipse Clinical Research
  Tucson, Arizona, United States Recruiting

+754 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.