Regeneron Reports Interim Data From Phase 2 COURAGE Study

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) Monday reported interim results from the ongoing Phase 2 COURAGE study evaluating semaglutide and trevogrumab with or without garetosmab for the treatment of obesity.

COURAGE study was designed to investigate the quality of weight loss in patients with obesity. The treatment is divided into two phases, each lasting 26 weeks. This includes a weight loss phase and a weight maintenance phase. During the weight-loss phase, patients were randomized to receive either Novo Nordisk's semaglutide (GLP-1 receptor agonist) alone or in combination with two different doses of trevogrumab (anti-GDF8/anti-myostatin), or higher-dose trevogrumab plus garetosmab (anti-activin A).

Interim results from the study showed that 34.5% of the weight loss induced by semaglutide was due to lean mass loss, while patients in all combination groups maintained more lean mass with greater fat loss from baseline compared to semaglutide alone. It was showed that combining semaglutide with muscle-preserving antibodies preserved lean mass by 50%-80%.

"These early insights from the COURAGE trial are consistent with recently published pre-clinical data in rodents and non-human primates, and clearly establish the principle that blocking GDF8 with or without activin A can preserve muscle and further increase fat loss in patients being treated with GLP-1 therapy, thereby improving the quality of weight loss," said George D. Yancopoulos, Board Co-Chair, President and Chief Scientific Officer at Regeneron.