Regeneron has announced new results from the phase 2 COURAGE trial evaluating trevogrumab (anti-GDF8/anti-myostatin) for its potential to prevent lean mass and muscle loss during GLP-1 receptor agonist-induced weight loss in people living with obesity.
The results of the trial were presented during a Scientific Symposium at the European Association for the Study of Diabetes (EASD) Annual Meeting and is in press with The Lancet.
Building on these positive findings, Regeneron is planning to initiate a phase 2 trial evaluating trevogrumab in combination with GLP-1 receptor agonist-based therapies in older adults with obesity and decreased muscle mass and/or strength.
COURAGE investigated the quality of weight loss in people living with obesity (BMI ≥30 kg/m2) in two independent portions over 52 weeks. A higher-dose portion evaluated trevogrumab (200mg or 400mg) in combination with semaglutide 2.4mg for 26 weeks compared to semaglutide alone, and then trevogrumab compared to placebo alone for an additional 26 weeks after semaglutide was discontinued. The trial also included a treatment arm with semaglutide, trevogrumab and an Activin-A inhibitor for which the results were previously presented.
“As GLP-1 receptor agonist-based medicines become foundational to obesity care, it is becoming increasingly recognized that the associated muscle loss is an increasing concern – particularly for people with sarcopenia, older adults and others where frailty is a real concern,” said Boaz Hirshberg, Senior Vice President, Clinical Development, Internal Medicine, Regeneron. “Our COURAGE trial not only confirms this concern about muscle loss but also shows that trevogrumab can be part of the solution, addressing not the quantity, but rather the quality, of weight loss. It’s an approach we’re building across our growing pipeline.”