Novo Nordisk’s Phase III REDEFINE 4 trial of CagriSema, a GLP‑1/amylin combination, failed to demonstrate non‑inferiority to Eli Lilly’s tirzepatide. The 84‑week, open‑label study enrolled 809 participants and reported an average weight loss of 23 % for CagriSema versus 25.5 % for tirzepatide, falling short of the pre‑specified margin.
The trial’s primary endpoint required CagriSema to achieve weight loss within a 2.5 % margin of tirzepatide. The 23 % loss did not meet that threshold, meaning the drug did not prove it could match tirzepatide’s efficacy. The study’s open‑label design and large sample size give the result high credibility, but the shortfall signals a challenge for Novo’s obesity strategy.
The miss is a setback for Novo’s obesity franchise, which had counted on CagriSema to replace Wegovy and capture market share from tirzepatide. The company’s 2026 sales guidance already projects a 5 %–13 % decline at constant exchange rates, citing pricing headwinds and market dynamics. A lower efficacy for CagriSema adds pressure to that outlook and raises doubts about future revenue streams from the obesity segment. Gross margin fell to 81 % from 84.7 % in 2024, partly due to amortization and restructuring costs.
Executive comments reflected both confidence in the drug’s potential and an acknowledgement of the setback. Martin Holst Lange said, "We are pleased with the weight loss of 23% for CagriSema in this open‑label trial. CagriSema has the potential to be the first GLP‑1/amylin‑combination product to reach the market for people living with obesity, documenting that cagrilintide adds to the existing benefits of semaglutide and offers clinically meaningful additive weight loss effects superior to what has been observed with GLP‑1 biology alone." CEO Maziar Mike Doustdar defended the product, stating, "To say it's obsolete is quite belittling a fantastic drug, in all honesty," and added, "When CagriSema will make it to the market early next year as the first amylin‑based product, it will have the best weight loss label than any product marketed at that time."
Novo plans to launch a higher‑dose CagriSema trial and is exploring other obesity pipeline assets. The company also continues to monitor tirzepatide’s performance and may adjust its positioning strategy to maintain competitiveness in the rapidly evolving obesity market.
Investors reacted negatively to the results, reflecting concerns about Novo’s ability to compete with tirzepatide and the broader implications for its obesity portfolio. The outcome underscores the intensity of competition in the obesity drug market and the importance of demonstrating clear clinical advantage.
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