Clinical TrialJul 31, 2026, 08:58 AM
Novo Nordisk ZEUS trial fails to reduce MACE
AI Summary
Novo Nordisk announced that its ZEUS cardiovascular outcomes phase 3 trial for ziltivekimab failed to meet its primary endpoint. The investigational drug did not reduce major adverse cardiovascular events (MACE) compared to placebo in people with atherosclerotic cardiovascular disease, chronic kidney disease, and inflammation. While ziltivekimab showed the expected biological effect of inhibiting the IL-6 pathway, this did not translate into clinical benefit. The company stated that this outcome will not affect its 2026 adjusted operating profit outlook but will lead to a non-cash impairment charge in Q3 2026.
Key Highlights
- ZEUS phase 3 trial for ziltivekimab did not reduce major adverse cardiovascular events (MACE) versus placebo.
- Hazard ratio for MACE was 0.99 (95% confidence interval, 0.88 to 1.11).
- Ziltivekimab demonstrated target engagement and inhibition of the IL-6 pathway.
- Overall adverse events were similar to placebo, but serious infections were higher with ziltivekimab.
- The outcome will not impact Novo Nordisk's 2026 adjusted operating profit outlook.
- A non-cash impairment charge will be recorded in Q3 2026.
- Two other ziltivekimab trials (HERMES, ARTEMIS) are continuing, with results expected in H1 2027.
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