ACCLAIM – Lp(a)

Purpose

Lepodisiran has the potential of demonstrating clinically meaningful improvements in 
cardiovascular disease (CVD) outcomes associated with lowering lipoprotein (a). This 
study will investigate the effect of lepodisiran on the reduction of major adverse cardiovascular events (MACE) in adults with elevated Lp(a) and established atherosclerotic cardiovascular disease (ASCVD) or who are at risk for a first cardiovascular (CV) event and provide additional evidence for the potential clinical benefits of lepodisiran in this population.

Description

Study J3L-MC-EZEF (EZEF) is a Phase 3, international, randomized, double-blind, placebo-controlled, parallel-group, event-driven study 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.

Approximately 12,500 participants will be randomly assigned in a 1:1 ratio to receive either lepodisiran or placebo, added to their existing standard-of-care background medications. 
The first 3 doses are 6 months apart. All remaining doses are 12 months apart (Q12M) until the 
end of the study.

As this is an event-driven study, the total study duration will be approximately 4.75 years until at 
least 1276 participants experience at least 1 component event of the primary composite endpoint. 
The minimum study duration for each participant is expected to be 2 years.
The final visit will occur during the study closeout period and approximately 30 or more days after a participant’s last dose.