Trial
ACCLAIM-Lp(a)
Status Ongoing, enrolment complete, primary completion March 2029
The largest Lp(a) outcomes trial: 17,300 adults with elevated Lp(a) who have established ASCVD or are at risk of a first cardiovascular event, randomised to lepodisiran (an extended-duration siRNA given by subcutaneous injection about every six months) or placebo. Started March 2024, no longer recruiting, primary completion expected March 2029.
Design. Phase 3, randomised, double-blind, placebo-controlled; MACE endpoint; both secondary- and high-risk primary-prevention populations, which will let it answer the primary-prevention question earlier than a dedicated trial.
Basis. Phase 1 (JAMA 2023): a single 608 mg dose kept Lp(a) 94 percent down at day 337. ALPACA phase 2 (NEJM 2025): 400 mg lowered time-averaged Lp(a) by 93.9 percent from day 60 to 180 and by 94.8 percent over a year with a second dose at day 180.
Related. A coronary plaque imaging study of lepodisiran (NCT07613294, n=252) started June 2026.
lepodisiranoutcomes trialphase 3primary preventionsecondary prevention
Page updated 17 August 2026.