Topline results from the Phase 3 Essence-TIMI 73b study provide encouraging evidence of the efficacy of olezarsen in patients with moderate hypertriglyceridaemia (fasting TG 150 mg/dL to <500 mg/dL) with or at risk of atherosclerotic cardiovascular disease (ASCVD).
The trial met its primary endpoint with statistically significant placebo-adjusted reductions in TG levels of 58% and 61% at six months with monthly olezarsen 50 mg and 80 mg, respectively (p <0.0001). Olezarsen also met all key secondary endpoints in the study, and most patients reached a TG <150mg/dL.
Olezarsen demonstrated a favourable safety and tolerability profile in the study. Data from the pivotal Phase 3 CORE and CORE2 studies evaluating olezarsen for the treatment of severe hypertriglyceridemia are expected in Q3 2025.
In Essence-TIMI 73b (NCT05610280), participants received stable, optimised standard of care lipid-lowering therapies for at least four weeks prior to screening. Participants were randomised to olezarsen 50 mg (n=276), 80 mg (n=832) or placebo (n=369) every 4 weeks via subcutaneous injection for 12 months.
