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, comparing CagriSema (2.4 mg cagrilintide and 2.4 mg semaglutide) to tirzepatide (15 mg) [2]. - The trial's design was open-label, meaning both investigators and participants were aware of the treatment being administered [2]. Efficacy 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 - The company is optimistic about CagriSema's potential as a first GLP-1/amylin-combination product for obesity treatment, with plans for further trials including REDEFINE 11 and a higher-dose trial [5]. - CagriSema was submitted to the US FDA in December 2025, with a decision expected by late 2026 [5]. - The REDEFINE 11 trial is anticipated to report data in the first half of 2027, while the higher-dose trial is set to begin in 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 increase feelings of fullness [7]. About the REDEFINE Programme - The REDEFINE programme is a phase 3 clinical development initiative that includes multiple trials aimed at assessing the efficacy and safety of CagriSema in various populations with obesity [8][9][10][11][12].