Novo Nordisk Updates on ZEUS Phase 3 Trial of Ziltivekimab
Saturday, August 01, 2026
Novo Nordisk has announced headline results from the Phase 3 ZEUS cardiovascular outcomes trial evaluating ziltivekimab in people with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD) and inflammation.
The study showed that ziltivekimab successfully engaged its intended target and inhibited the interleukin-6 (IL-6) pathway, as demonstrated by expected reductions in free IL-6 and high-sensitivity C-reactive protein (hsCRP). However, these biological effects did not lead to a reduction in the risk of major adverse cardiovascular events (MACE) compared with placebo.
ZEUS was a randomised, double-blind, placebo-controlled Phase 3 trial involving more than 6,300 participants with ASCVD, CKD and inflammation, identified by hsCRP levels of at least 2 mg/L. The trial assessed once-monthly treatment with 15 mg of ziltivekimab against placebo to determine its ability to reduce the risk of MACE, including cardiovascular death, non-fatal heart attack and non-fatal stroke.
The findings indicate that although the treatment reduced markers of cardiovascular inflammation by blocking the IL-6 pathway, it did not improve cardiovascular outcomes in the study population. Novo Nordisk said the results provide important scientific evidence that will support its ongoing cardiovascular research and future treatment development. The company also confirmed that the outcome does not alter its long-term commitment to cardiovascular disease research.
The safety profile of ziltivekimab was generally consistent with placebo, with similar overall rates of adverse events and serious adverse events. However, serious infections occurred more frequently among patients receiving ziltivekimab, in line with the expected effects of IL-6 inhibition. There was no difference in all-cause mortality between the treatment and placebo groups.
Novo Nordisk confirmed that its two ongoing cardiovascular outcomes trials of ziltivekimab, HERMES in heart failure and ARTEMIS in patients recovering from an acute heart attack, will continue as planned. Both studies are expected to report results in the first half of 2027.
The company also stated that the ZEUS trial outcome will not affect its previously announced adjusted operating profit outlook for 2026. However, it expects to record a non-cash impairment charge in the third quarter of 2026.
Detailed findings from the ZEUS trial will be presented at a scientific meeting later in 2026.
Source: globenewswire.com
