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A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event
Who can join
Ages 45 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: * Have an Lp(a) ≥175 nmol/L * Have established cardiovascular (CV) disease or are at risk for a first CV event * Have angiographic evidence of coronary artery disease on screening CCTA * If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks Exclusion Criteria: * Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening * Have moderate to severe renal dysfunction * Have severe heart failure * Have a history of coronary artery bypass graft surgery (CABG) * Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention * Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a) * Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical/technical factors
About the study
Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a).
Participation will last about 120 weeks.
What is being tested
- Lepodisiran (drug)
- Placebo (drug)
Sponsor: Eli Lilly and Company · Participants: 252 · Started: Jun 1, 2026
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 317-615-4559
Official record on ClinicalTrials.gov — NCT07613294
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.