In the Phase 3 REDEFINE 4 trial, CagriSema achieved 20.2-23.0% weight loss after 84 weeks, compared to 23.6-25.5% for Zepbound (tirzepatide), failing to meet the non-inferiority endpoint2345.
The open-label trial involved 809 patients with obesity and comorbidities, showing CagriSema's gastrointestinal side effects were mild to moderate and consistent with GLP-1RA class3.
Novo Nordisk submitted CagriSema for FDA approval in December 2025, with a decision expected by late 2026; executives remain optimistic about its 23% weight loss and potential as first GLP-1/amylin combo35.
The results add pressure on Novo Nordisk's obesity strategy amid competition from Lilly, with Novo shares dropping and analysts noting Lilly's extended advantage156.
Sources:
1. https://global.morningstar.com/en-gb/stocks/novo-nordisk-another-disappointing-cagrisema-trial-adds-pressure-high-dose-strategy
2. https://www.biopharmadive.com/news/novo-nordisk-cagrisema-zepbound-head-to-head-results/812810/
3. https://www.clinicaltrialsarena.com/news/novo-nordisks-cagrisema-bested-by-lillys-zepbound-in-head-to-head-trial/
4. https://www.statnews.com/2026/02/23/novo-nordisk-cagrisema-fail-comparison-trial-zepbound-eli-lilly-obesity/
5. https://www.fiercebiotech.com/biotech/novos-cagrisema-loses-phase-3-battle-mounjaro-knocking-15-share-price