Ziltivekimab - (ZEUS)

July 31, 2026: Novo Nordisk reported headline results from the Phase 3 ZEUS cardiovascular outcomes trial of ziltivekimab in people with atherosclerotic cardiovascular disease, chronic kidney disease, and inflammation (hsCRP ≥2 mg/L). In the over-6,300-patient, double-blind, placebo-controlled study, once-monthly ziltivekimab 15 mg did not reduce 3-point MACE versus placebo (HR 0.99; 95% CI 0.88-1.11), missing the primary endpoint.

Ziltivekimab showed expected IL-6 pathway target engagement, with reductions in free IL-6 and hsCRP, but this did not translate into cardiovascular benefit. Overall adverse event and serious adverse event rates were similar to placebo, but serious infections were more frequent with ziltivekimab; no difference in all-cause mortality was observed.

Novo Nordisk said the ZEUS outcome will not affect its previously communicated 2026 adjusted operating profit outlook, though it will record a non-cash impairment charge in Q3 2026. Full ZEUS results will be presented at an upcoming scientific meeting in 2026.

The company also said two other ongoing ziltivekimab cardiovascular outcomes trials will continue: HERMES in heart failure and ARTEMIS after acute heart attack, with both readouts anticipated in 1H 2027.