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Novo Nordisk (NVO) is plunging to multi-year lows after CagriSema failed to meet the primary endpoint in the open-label, head-to-head REDEFINE 4 obesity trial versus Eli Lilly's (LLY) tirzepatide. The readout is another blow to the obesity and diabetes drugmaker, which is already dealing with U.S. pricing pressure, intensifying competition, and semaglutide patent expiries in some markets, and it comes after November's negative EVOKE Alzheimer's Phase 3 readout and Pfizer's (PFE) win in the Metsera deal.
- CagriSema is NVO's once-weekly fixed-dose obesity candidate that combines semaglutide and cagrilintide, while tirzepatide is the active ingredient in LLY's Mounjaro and Zepbound.
- Specifically, patients treated with CagriSema achieved 23.0% weight loss after 84 weeks, versus 25.5% for tirzepatide, failing to meet the primary endpoint despite a strong absolute weight-loss result.
- The weaker CagriSema comparison also reinforces the recent divergence in the two companies. LLY recently guided FY26 revenue to $80-83 bln, implying roughly 25% growth, while NVO guided for FY26 adjusted sales growth of -5% to -13%.
- That divergence is also showing up in commercial momentum. LLY posted blockbuster growth in FY25 from its tirzepatide franchise, with Mounjaro up 99% and Zepbound up 175%, while NVO still delivered strong obesity growth, but at a slower pace, with obesity care sales up 31% and U.S. obesity growth of 15%.
- NVO is still positioning REDEFINE 4 as one piece of a broader obesity pipeline, with REDEFINE 11 expected in 1H27 to assess CagriSema's full weight-loss potential and a higher-dose CagriSema phase 3 trial planned for 2H26.
Briefing.com Analyst Insight
While 23% weight loss is a strong result in absolute terms, this was a head-to-head trial and a key opportunity for NVO to show CagriSema could compete more directly with LLY's tirzepatide, and it fell short, which explains the sharp sell-off. The issue is less about whether CagriSema works and more about competitive positioning, as LLY's tirzepatide delivered better weight-loss results in the trial and reinforced the current gap between the two. That miss also reflects the broader divergence in momentum, with LLY posting stronger obesity growth while NVO contends with pricing pressure, competition, and recent pipeline setbacks. That said, this likely does not close the book on CagriSema. NVO is still pointing to additional obesity trials, including REDEFINE 11 and a higher-dose study, and the company is also building around other growth levers such as the Wegovy pill and broader obesity pipeline efforts. Still, after this readout, the gap between the two appears wider, and investors may stay on the sidelines until NVO can show clearer evidence that it is narrowing the competitive gap.