Regeneron Pharmaceuticals (Nasdaq: REGN) reported 52-week data from the Phase II COURAGE trial showing that trevogrumab, an anti-myostatin antibody, reduced lean-mass and muscle loss in people with obesity receiving semaglutide. The findings were presented at the European Association for the Study of Diabetes Annual Meeting and have been accepted for publication in The Lancet.
At 52 weeks, participants receiving trevogrumab 75 mg plus semaglutide had a 4.2% reduction in lean mass versus 7.3% with semaglutide alone, corresponding to 42.5% relative preservation of lean mass. The 25 mg dose produced 20.5% relative preservation. In a predefined MRI substudy, the two lower trevogrumab doses preserved approximately 69%–72% of thigh muscle volume that would otherwise have been lost with semaglutide alone.
Lower-dose trevogrumab did not meaningfully increase overall weight loss beyond that achieved with semaglutide, suggesting its effect was primarily on the composition rather than magnitude of weight loss. In a prespecified subgroup with low lean mass at baseline, participants receiving semaglutide alone lost more lean mass than those without low lean mass, while numerically greater preservation was seen with trevogrumab.
Trevogrumab blocks GDF8, or myostatin, a negative regulator of skeletal muscle growth. The lower doses were generally well tolerated, with 77% of participants experiencing at least one adverse event versus 82% in the placebo-plus-semaglutide group; the most common events included nausea, constipation, diarrhea, and vomiting.