Regeneron’s announces results of Phase 2 trial of semaglutide+trevogrumab

Regeneron (REGN) Pharmaceuticals “announced interim results from the ongoing Phase 2 COURAGE trial investigating novel combinations of semaglutide, GLP-1 receptor agonist, and trevogrumab with or without garetosmab for the treatment of obesity. The trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab helped preserve lean mass while increasing loss of fat mass. The interim analysis was conducted when 50% of patients reached week 26 in the trial. The combination of semaglutide with trevogrumab was generally well-tolerated; the triplet combination of semaglutide with both antibodies had a substantially higher rate of discontinuations due to tolerability issues and other adverse events, consistent with the safety profile previously seen with garetosmab alone. COURAGE was designed to investigate the quality of weight loss in patients with obesity. Treatment is divided into two 26-week periods comprised of a weight-loss phase and a weight-maintenance phase. The three primary efficacy endpoints were assessed in this interim analysis when 50% of patients reached week 26, and included percent change from baseline at week 26 in lean mass, fat mass and body weight. During the weight-loss phase, patients were randomized to receive semaglutide alone or in combination with two different doses of trevogrumab (lower- or higher-dose combo), or higher-dose trevogrumab plus garetosmab. At this interim analysis, 34.5% of semaglutide-induced weight loss was due to lean mass loss, while patients in all combination groups preserved more lean mass with greater fat loss from baseline compared to semaglutide alone.”