A Phase 3 interventional study of Muvalaplin and Placebo in Elevated Lp(a) and Atherosclerotic Cardiovascular Disease (ASCVD), sponsored by Eli Lilly and Company. Recruiting at 804 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's planned enrollment of 10,450 is above the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meet one of the following criteria:
Are at risk for a first ASCVD event, defined as one or more of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive muvalaplin orally.
Drug: Muvalaplin
Participants will receive placebo orally.
Drug: Placebo
Administered orally
Also known as: LY3473329
Administered orally
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.
Time frame: Baseline up to End of Study (About 5.25 Years)
Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4
Time frame: Baseline, Week 4
Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to First Occurrence of Any Component of the Coronary MACE-3 Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to First Occurrence of Any Component of MACE-3 + Major Adverse Limb Event (MALE) Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to Occurrence of All-Cause Mortality
Time frame: Baseline up to End of Study (About 5.25 Years)
Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint
Time frame: Baseline up to End of Study (About 5.25 Years)
Change from Baseline to Each Annual Visit for Health-Care Resource Utilization (HCRU)
Time frame: Baseline up to End of Study (About 5.25 Years)
Pharmacokinetics (PK): Trough Concentration at Steady State (C-trough, ss) of Muvalaplin
Time frame: Predose through Week 96
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 804 sites across 28 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Sep 2025 (actual). Primary completion is estimated for Mar 2031, 66 months after the start.
Of 36 industry-sponsored phase 3 interventional studies under Atherosclerosis, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 51. This study's planned 66 months is above that.
Counting every sponsor, half of 53 studies reached it within 35 months; a quarter within 21 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Muvalaplin