ACCLAIM - EZEF
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event – ACCLAIM-Lp(a)
IRAS ID
1009304
Contact name
Andres Gomez
Contact email
Sponsor organisation
Eli Lilly and Co.
Research summary
There are currently millions of adults who suffer from cardiovascular disease. Human epidemiologic and genetic evidence using the Mendelian randomization approach strongly supports that elevated Lp(a) is an independent and causal risk factor for CVD, with association to coronary heart disease, stroke, chronic kidney disease, aortic valve stenosis, heart failure, and peripheral vascular disease.
Lepodisiran sodium (lepodisiran) is a novel Dicer-substrate siRNA oligonucleotide designed to
reduce the levels of LPA mRNA and Apo(a) expression and thereby to decrease the Lp(a) level.
Lepodisiran is being developed to reduce the risk of MACE in patients with high levels of Lp(a)
and established ASCVD or at risk of CV events.
Study EZEF is a Phase 3 study that aims to investigate the reduction of MACE with lepodisiran treatment compared to placebo in adult participants with established ASCVD or are at risk for a first CV event. Study EZEF will investigate the effect of lepodisiran on the reduction of MACE in adults with elevated Lp(a) and established ASCVD or who are at risk for a first CV event and provide additional evidence for the potential clinical benefits of lepodisiran in this population.
Participants will be randomly assigned to receive either lepodisiran or placebo.
Patient participation is expected to last up to 5 years. The patient will receive treatment for approximately 4 years. Approximately 12 500 participants will be enrolled in the study globally, including approximately 185 participants from the UK.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0025
Date of REC Opinion
14 Mar 2024
REC opinion
Further Information Favourable Opinion