Novartis’s Pelacarsen Fails to Reduce Cardiovascular Risk in Phase 3 Trial

Novartis said its experimental drug pelacarsen failed to reduce major cardiovascular events in the Phase 3 Lp(a)HORIZON trial.

The trial enrolled 8,323 patients with established cardiovascular disease and elevated lipoprotein(a), or Lp(a), a largely genetic risk factor linked to heart disease.

Although pelacarsen substantially lowered Lp(a) levels, it did not significantly reduce the composite endpoint of cardiovascular death, nonfatal heart attack, nonfatal stroke, or urgent coronary revascularization compared with placebo.

The result is a major setback for Novartis and Ionis Pharmaceuticals and raises doubts about whether lowering Lp(a) alone prevents heart attacks and strokes.

The findings also complicate development efforts by competitors, including Eli Lilly and Amgen, though analysts said the result does not definitively disprove Lp(a) as a treatment target.

Novartis has not yet released detailed event rates, effect sizes, or subgroup findings. Full results are expected at a future medical conference.