On July 31, Novo-Nordisk A/S unveiled top-line Phase 3 results from its ZEUS cardiovascular trial today. While ziltivekimab demonstrated target engagement and inhibition of the IL-6 pathway, evidenced by anticipated reductions in free IL-6 and high-sensitivity C-reactive protein (hsCRP), these biological effects did not translate into a lower risk of major adverse cardiovascular events (MACE) versus placebo among patients living with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD) and inflammation (hazard ratio, 0.99; 95% confidence interval, 0.88–1.11).

Novo-Nordisk A/S fell over 10% in pre-market trading.

Meanwhile, a US court recently ruled that Novo Nordisk must face certain shareholder allegations related to statements made about its next-generation weight-loss drug CagriSema's clinical trials, marking a material escalation of litigation risk. The lawsuit stems from CagriSema's failure to achieve the company's projected 25% average weight loss target in Phase III trials, with multiple shareholders alleging disclosure violations.

Novo Nordisk responded that the allegations are baseless and pledged to mount a full defense.

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