Interim Results from Ongoing Phase 2 COURAGE Trial Confirm Potential to Improve the Quality of Semaglutide (GLP-1 receptor agonist)-induced Weight Loss by Preserving Lean Mass

Core Insights - Regeneron Pharmaceuticals announced interim results from the Phase 2 COURAGE trial, showing that approximately 35% of weight loss from semaglutide was due to lean mass loss, and combining it with trevogrumab helped preserve lean mass while increasing fat loss [1][2][3] Group 1: Trial Results - The COURAGE trial demonstrated that combining semaglutide with trevogrumab, with or without garetosmab, preserved 50%-80% of lean mass compared to semaglutide alone while enhancing fat mass loss [1][2] - At the 26-week interim analysis, patients receiving semaglutide alone lost an average of 7.9 lbs of lean mass, while those on the lower-dose and higher-dose combinations lost 3.7 lbs and 4.2 lbs respectively, and the triplet group lost only 2.0 lbs [3][4] - Fat mass loss was significantly higher in combination groups, with the triplet group losing an average of 25.4 lbs, representing an 84.4% change from baseline [3][4] Group 2: Safety and Tolerability - The combination therapies were generally well-tolerated, but the triplet combination had a higher rate of treatment discontinuation due to tolerability issues, with 28.3% of participants discontinuing treatment [1][6] - The overall incidence of treatment-emergent adverse events (TEAEs) was 64.9% for semaglutide monotherapy, increasing to 77.2% in the triplet group [6] Group 3: Future Directions - The full data set from the COURAGE trial is expected to be available later this year, which will provide further insights for optimizing dosing regimens in future trials [2] - Regeneron is focused on developing treatments that improve the quality of weight loss by preserving muscle mass during weight reduction, addressing a significant concern in obesity management [7][8]