Status:
RECRUITING
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Elevated Lp(a)
Atherosclerotic Cardiovascular Disease (ASCVD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 a...
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
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
10450 Patients enrolled
Trial Details
Trial ID
NCT07157774
Start Date
September 2 2025
End Date
March 1 2031
Last Update
December 18 2025
Active Locations (683)
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1
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Phoenix, Arizona, United States, 85014
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