Trial
Lp(a)HORIZON
Status Completed, results awaited
The first cardiovascular outcomes trial of any Lp(a)-lowering therapy: 8,323 patients with prior myocardial infarction, ischaemic stroke or symptomatic peripheral artery disease and Lp(a) of 70 mg/dL (about 149 nmol/L) or more, randomised to monthly subcutaneous pelacarsen 80 mg or placebo, event-driven to 993 adjudicated MACE. Primary completion was set for 30 June 2026; Novartis and Ionis guided the readout to the second quarter of 2026 and it has not been announced as of mid-August 2026.
Design. Phase 3, randomised, double-blind, placebo-controlled, multinational; 1:1 to pelacarsen 80 mg every 4 weeks or placebo on optimised standard of care; minimum follow-up 2.5 years; primary endpoint time to first MACE (CV death, non-fatal MI, non-fatal stroke, urgent coronary revascularisation), with a second primary analysis in patients with Lp(a) of 90 mg/dL or more. Started December 2019, enrolment completed 2022. Design paper: Cho, Nicholls, Nordestgaard et al., Am Heart J 2025.
Why it matters. Mendelian randomisation says about 65 to 100 mg/dL of Lp(a) lowering should equal 1 mmol/L of LDL-C lowering; pelacarsen lowers Lp(a) by about 80 percent from these baselines. A positive result establishes the Lp(a) hypothesis and a class; a neutral result sends the field back to the mechanisms.
Companion trials. Lp(a)FRONTIERS APHERESIS (NCT05305664, published EHJ 2026): pelacarsen replaced weekly apheresis in 25 of 26 German patients. Lp(a)FRONTIERS CVD (NCT05646381, phase 2, n=502, running to 2030). US Black/African American and Hispanic Lp(a)-lowering study (NCT06267560, completed 2026); pelacarsen with background inclisiran (NCT06813911); open-label extensions (NCT05900141, NCT06875973, NCT07517263).
Where to look. ESC Congress 2026 (München, 28 to 31 August) and AHA 2026 (November) are the natural venues if the trial reads out in the second half of 2026.
outcomes trialpelacarsenphase 3secondary prevention
Page updated 17 August 2026.