Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on Reducing Major Cardiovascular Events in Adults With Elevated Lipoproteina
Led by Eli Lilly and Company · Updated on 2026-06-03
10450
Participants Needed
752
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying muvalaplin to see if it can reduce the risk of major heart problems in adults with high levels of lipoproteina who have cardiovascular disease or are at risk of a heart attack or stroke. This Phase 3 trial is designed to provide strong evidence by comparing muvalaplin to a placebo in a large group of participants over several years. The study is sponsored by Eli Lilly and Company and focuses on adults with atherosclerotic cardiovascular disease or those at risk for it. Participants will be randomly assigned to receive either muvalaplin or a placebo, both taken by mouth. The trial is double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo. The study will last about 5.25 years, during which participants will be monitored closely. The primary goal is to measure the time until the first major adverse cardiac event occurs, including heart attacks and strokes. During the study, participants will have regular visits for assessments, including blood tests to measure lipoproteina levels and pharmacokinetics of muvalaplin over the first 96 weeks. Researchers will track the occurrence of cardiovascular events, deaths, and healthcare resource use annually. Safety and adherence will be monitored throughout the study to ensure participant well-being and accurate data collection.
CONDITIONS
Brief Title
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have lipoprotein(a) levels of 175 nanomoles per liter (nmol/L) or higher
- Have had a prior atherosclerotic cardiovascular disease event within 10 years before screening
- Or be at risk for a first cardiovascular event due to documented coronary artery disease, carotid stenosis, peripheral artery disease without previous events, a high coronary artery calcium score, reduced kidney function with diabetes, or combinations of high risk factors
- Be aged 18 years or older
You will not qualify if you...
- Experienced a major cardiovascular event or surgery within 90 days before screening or between screening and randomization
- Planning or expected to have a procedure to restore blood flow in arteries or major heart surgery during the study
- Have uncontrolled high blood pressure
- Have New York Heart Association class III or IV heart failure
- Had a procedure to remove cholesterol from blood within 90 days before screening or planned during the study
- Have severe kidney impairment
- Had cancer within 5 years before screening
Research Team
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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