Novo Nordisk A/S (NVO) announced disappointing headline results from its Phase 3 study evaluating CagriSema in people with obesity, sending shares down over 15%.
In the trial, dubbed REDEFINE 4, CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) was compared to Lilly's Zepbound (tirzepatide 15 mg), both administered once-weekly and subcutaneously, in adults with obesity.
According to the trial results, the primary endpoint of non-inferiority was not achieved.
Obesity is a chronic condition associated with multiple comorbidities, and effective weight management remains a critical unmet need.
The REDEFINE 4 trial enrolled 809 participants with obesity and at least one comorbidity, with a mean baseline body weight of 114.2 kg.
The trial's open-label design allowed both the investigator and participants to know which treatment was administered. Results showed:
-- When taken as directed, if all people adhered to treatment, CagriSema 2.4/2.4 mg helped patients lose 23.0% of their body weight after 84 weeks.-- Under the same ideal conditions, tirzepatide 15 mg led to a 25.5% weight loss after 84 weeks.-- In an analysis that reflects real-world use, CagriSema resulted in 20.2% weight loss compared to 23.6% with tirzepatide.
While the primary endpoint of non-inferiority was not met, CagriSema demonstrated a safe and well-tolerated profile, the company noted. The most common adverse events were gastrointestinal, mostly mild to moderate, and diminished over time.
Martin Holst Lange, Executive Vice President of R&D and Chief Scientific Officer at Novo Nordisk, stated: "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."
Upcoming Milestones
• FDA Submission: The New Drug Application for CagriSema for weight management was submitted to the U.S. FDA in December 2025 based on REDEFINE 1 and REDEFINE 2 pivotal trials. A decision is expected by late 2026.
• REDEFINE 11 Trial: Designed to assess the full weight-loss potential of CagriSema 2.4/2.4 mg, with results anticipated in the first half of 2027.
• High-Dose Trial: A Phase 3 study of higher-dose CagriSema is planned to begin in the second half of 2026.
NVO has traded between $43.08 and $93.80 over the past year. On February 20, 2026, the stock closed at $47.42, down 2.13%. In the pre-market, NVO fell to $40.54, down 14.51%, marking a new 52-week low.
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