Novo Nordisk's CEO: We strongly believe that CagriSema has right now the best weight efficacy than any product currently on the market

Novo Nordisk's CEO: We strongly believe that CagriSema has right now the best weight efficacy than any product currently on the market

Novo Nordisk’s CagriSema Trial Falls Short of Non-Inferiority Target, Despite Strong Weight Loss

Novo Nordisk A/S (NOVOB.CO) announced on February 23, 2026, that its experimental obesity drug CagriSema did not meet the primary endpoint of non-inferiority to Eli Lilly’s tirzepatide in the REDEFINE 4 phase 3 trial according to the company announcement. The open-label study, which enrolled 809 participants with obesity and comorbidities, evaluated CagriSema (a fixed-dose combination of cagrilintide and semaglutide) against tirzepatide 15 mg over 84 weeks. While CagriSema achieved a 23.0% weight loss under an efficacy estimand (assuming full adherence), tirzepatide demonstrated a 25.5% reduction. Under a treatment-regimen estimand (accounting for adherence), CagriSema’s weight loss was 20.2% versus 23.6% for tirzepatide according to the trial results.

Despite the setback, Novo Nordisk emphasized CagriSema’s 23% weight loss as a “clinically meaningful” result, with CEO Martin Holst Lange stating the drug could become the first GLP-1/amylin combination therapy for obesity. The company cited the drug’s safety profile, noting gastrointestinal adverse events were mostly mild to moderate and consistent with the GLP-1 class.

The REDEFINE 4 results contrast with Novo Nordisk’s recent regulatory submissions. The company submitted CagriSema for FDA approval in December 2025 based on earlier trials (REDEFINE 1 and 2), with a decision expected by late 2026. However, the failure to demonstrate non-inferiority in REDEFINE 4 raises questions about its competitive positioning against tirzepatide, which is marketed as Zepbound for obesity.

Novo Nordisk plans to explore higher-dose combinations in a phase 3 trial starting in late 2026 and awaits results from REDEFINE 11 in mid-2027. Meanwhile, the stock fell over 8% in early trading following the announcement, reflecting investor concerns about the drug’s market potential.

While the company remains optimistic about CagriSema’s long-term prospects, the REDEFINE 4 outcome underscores the challenges of competing in a rapidly evolving obesity drug landscape.