NVO's CagriSema Outshines Semaglutide in Phase III Diabetes Study

Core Insights - Novo Nordisk (NVO) announced positive top-line data from its late-stage REIMAGINE clinical study program for CagriSema, a next-generation treatment for type II diabetes (T2D) [1] Group 1: CagriSema Efficacy - CagriSema is a fixed-dose combination of cagrilintide (2.4 mg) and Wegovy (semaglutide 2.4 mg), showing superior HbA1c reduction and weight loss at week 68 compared to semaglutide across all tested doses [2] - In the phase III REIMAGINE 2 study, CagriSema demonstrated a 1.91 percentage-point reduction in HbA1c from a baseline of 8.2%, compared to a 1.76 percentage-point reduction with semaglutide [4] - Patients receiving the higher CagriSema dose achieved a 14.2% reduction in body weight from a mean baseline of 101 kg, compared to a 10.2% reduction with semaglutide [5] Group 2: Study Details - The phase III REIMAGINE 2 study involved 2,728 adults with T2D inadequately controlled with metformin, comparing two CagriSema doses against semaglutide and placebo [3] - Approximately 40% of participants were already using an SGLT2 inhibitor, providing insights into CagriSema's performance in common treatment backgrounds [3] Group 3: Safety Profile - CagriSema's safety profile was consistent with established incretin and amylin therapies, with mostly mild gastrointestinal events that tended to diminish over time [10] - The treatment regimen estimand analysis showed a superior HbA1c reduction of 1.80 percentage points and weight loss of 12.9% for CagriSema compared to semaglutide's 1.68 percentage points and 9.2% weight loss [9] Group 4: Future Development - Novo Nordisk is evaluating CagriSema in additional phase III studies for T2D and obesity, with plans to discuss regulatory pathways following positive data from the REIMAGINE and REDEFINE studies [11][12] - A regulatory application for CagriSema to reduce excess body weight is expected to be reviewed by the FDA in 2026 [13][14]