Novo Nordisk A/S: CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity, the primary endpoint was not achieved

Core Insights - Novo Nordisk announced results from the REDEFINE 4 trial, which investigated the efficacy of CagriSema compared to tirzepatide in individuals with obesity and comorbidities [1][2] Trial Overview - REDEFINE 4 was an 84-week open-label trial involving 809 participants with a mean baseline body weight of 114.2 kg [2] - The trial compared CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) to tirzepatide (15 mg), both administered once weekly [2] Weight Loss Results - Participants treated with CagriSema achieved a weight loss of 23.0% after 84 weeks, compared to 25.5% with tirzepatide [3] - When applying the treatment-regimen estimand, CagriSema resulted in a weight loss of 20.2%, while tirzepatide achieved 23.6% [3] - The trial did not meet its primary endpoint of demonstrating non-inferiority in weight loss for CagriSema compared to tirzepatide [3] Safety Profile - CagriSema exhibited a safe and well-tolerated profile, with the most common adverse events being mild to moderate gastrointestinal issues that diminished over time [4] Future Developments - Novo Nordisk is optimistic about CagriSema's potential as a first GLP-1/amylin-combination product for obesity treatment [5] - The company anticipates an FDA decision on CagriSema for weight management by late 2026, following its submission in December 2025 [5] - Upcoming trials include REDEFINE 11, expected to report data in the first half of 2027, and a higher-dose CagriSema trial planned for the second half of 2026 [5] About CagriSema - CagriSema is a once-weekly subcutaneous treatment being investigated for adults with obesity and type 2 diabetes, combining cagrilintide and semaglutide to reduce hunger and calorie intake [7] About the REDEFINE Programme - The REDEFINE programme is a phase 3 clinical development initiative that includes multiple trials assessing the efficacy and safety of CagriSema in various populations [8][9][10][11][12]