Novo Nordisk's CagriSema fails to match tirzepatide in obesity trial

Novo Nordisk A/S (NYSE: NVO) announced that its experimental obesity drug CagriSema did not achieve its primary endpoint in a phase 3 trial comparing it to Eli Lilly's tirzepatide.

The REDEFINE 4 trial, an 84-week open-label study involving 809 participants with obesity, showed CagriSema achieved 23.0% weight loss compared to 25.5% with tirzepatide when assuming full treatment adherence. Under the treatment-regimen analysis, CagriSema resulted in 20.2% weight loss versus 23.6% for tirzepatide.

The trial failed to demonstrate non-inferiority of CagriSema compared to tirzepatide after 84 weeks. CagriSema combines cagrilintide 2.4 mg and semaglutide 2.4 mg in a fixed-dose combination administered weekly by injection.

Participants had a mean baseline body weight of 114.2 kg and included people with obesity and one or more related health conditions. The company reported CagriSema showed a safe and well-tolerated profile, with mostly mild to moderate gastrointestinal side effects that decreased over time.

"CagriSema has the potential to be the first GLP-1/amylin-combination product to reach the market for people living with obesity," said Martin Holst Lange, executive vice president of R&D at Novo Nordisk.

The company submitted CagriSema for weight management to the U.S. Food and Drug Administration in December 2025 based on earlier REDEFINE 1 and REDEFINE 2 trials. An FDA decision is expected by late 2026. Additional trial data from the REDEFINE 11 study is anticipated in the first half of 2027.

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