Trevogrumab, semaglutide with and without garetosmab - (COURAGE)

October 1, 2026: Regeneron Pharmaceuticals (NASDAQ: REGN) reported Phase 2 COURAGE data at the EASD Annual Meeting for trevogrumab (anti-GDF8/anti-myostatin) plus semaglutide 2.4 mg in obesity, aimed at preserving lean mass/muscle during GLP-1-induced weight loss. In the 52-week lower-dose portion, the primary endpoint was met: versus placebo + semaglutide, lean mass loss by DXA was reduced from -7.3% to -5.8% with trevogrumab 25 mg (20.5% preservation) and to -4.2% with 75 mg (42.5% preservation) at week 52; at week 26, lean mass loss was -6.7% for placebo, -4.7% for 25 mg, and -3.3% for 75 mg. MRI substudy data showed thigh fat-free muscle volume loss with semaglutide alone (-1.03 at week 52) was reduced by 71.8% with 25 mg and 68.9% with 75 mg trevogrumab. Lower-dose trevogrumab did not meaningfully enhance weight loss versus semaglutide alone and was generally well tolerated; 77% had at least one AE versus 82% on placebo, with nausea, constipation, diarrhea, and vomiting most common. A pre-specified subgroup with low lean mass/sarcopenia had greater lean mass loss on semaglutide alone and numerically greater preservation with trevogrumab. Regeneron said it plans a new Phase 2 trial of trevogrumab plus GLP-1-based therapy in older adults with obesity and reduced muscle mass/strength. Hansoh also presented Phase 3 obesity data in Chinese patients for olatorepatide, a GLP-1/GIP agonist licensed to Regeneron outside mainland China, Hong Kong, and Macau.