Ionis Reports Promising Phase III Results for Olezarsen in Hypertriglyceridemia

Ionis Pharmaceuticals, in collaboration with the TIMI Study Group, announced positive topline results from the Phase III Essence trial evaluating olezarsen (Tryngolza) in patients with moderate hypertriglyceridemia and/or at risk for atherosclerotic cardiovascular disease (ASCVD). The randomized, double-blind, placebo-controlled study enrolled 1,478 adults, 9% of whom had baseline triglyceride (TG) levels of ≥500mg/dL. Participants received either 50mg or 80mg olezarsen or placebo via monthly subcutaneous injection over 12 months.

The primary endpoint—percentage change in fasting TG levels at six months—was met, with TG reductions of 61% and 58% (placebo-adjusted) for the 80mg and 50mg doses, respectively. All key secondary endpoints, including TG reductions at 12 months and normalization to <150mg/dL, were achieved. Olezarsen also showed a favorable safety profile. This investigational RNA-targeted therapy works by reducing apolipoprotein C-III (apoC-III), a key regulator of TG metabolism.

02-06-2025