Novo Nordisk halts two more ziltivekimab heart trials on futility finding
- Novo Nordisk is stopping two Phase 3 trials, HERMES and ATHENA, of ziltivekimab early after a data monitoring committee flagged futility.
- Ziltivekimab is an antibody that targets interleukin-6 (IL-6), an inflammatory cytokine, and the trials were testing it in heart failure patients with inflammation.
- The committee concluded neither trial was likely to produce a different result from the earlier Phase 3 ZEUS trial, which missed its cardiovascular endpoint in July.
- HERMES tracked time to cardiovascular death or heart failure-related hospitalization/urgent visits; ATHENA measured broader heart failure outcomes including quality of life.
- Novo Nordisk is continuing a separate Phase 3 trial, ARTEMIS, testing ziltivekimab as an acute post-heart-attack treatment, with a readout expected in the first half of 2027.
- The repeated failures raise doubts about IL-6 inhibition as a viable cardiovascular treatment strategy.
Three strikes on cardiovascular endpoints now — ZEUS in July, HERMES and ATHENA today — and Novo isn't spinning this as a design problem anymore; the DMC futility call is about as clear a kill signal as you get. Sunk cost here isn't trivial: ziltivekimab was Novo's flagship diversification bet outside GLP-1s, and this guts the broader inflammation-in-CV thesis that Novartis also struggled to validate with canakinumab post-CANTOS. IL-6 as a druggable node for heart failure now looks structurally shaky, not just underpowered. ARTEMIS surviving to 2027 reads less like conviction and more like sunk-cost inertia — acute post-MI biology differs, but a quiet wind-down before readout wouldn't surprise me if enrollment softens. Zoom out and this underscores just how thin Novo's non-GLP-1 pipeline really is, right as obesity/diabetes competition intensifies.
Updated: Novo Nordisk cans two more trials of IL-6 heart drug for futility ↗