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NCT07157774
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
Conditions: Elevated Lp(a), Atherosclerotic Cardiovascular Disease (ASCVD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 10450
Sponsor: Eli Lilly and Company
Location: Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC Gilbert Arizona
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 attack or stroke.
Eligibility 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
Source: ClinicalTrials.gov (NCT07157774). StuddyBuddy aggregates publicly available trial information.