Regeneron said its investigational antibody trevogrumab preserved lean mass and thigh muscle volume in adults with obesity taking semaglutide in the Phase 2 COURAGE trial.
The 52-week study evaluated lower-dose trevogrumab, at 25 mg or 75 mg, combined with semaglutide 2.4 mg, against semaglutide plus placebo. The primary endpoint was change in lean mass measured by dual-energy X-ray absorptiometry, or DXA.
At week 52, participants receiving semaglutide plus placebo had lost 7.3% of baseline lean mass. Lean-mass loss was 5.8% with the 25-mg trevogrumab dose and 4.2% with the 75-mg dose. Regeneron calculated that the two doses preserved 20.5% and 42.5%, respectively, of lean mass that otherwise would have been lost with semaglutide alone.
The higher trevogrumab dose preserved 50.7% of lean mass at week 26, when participants on semaglutide plus placebo had lost 6.7% of baseline lean mass. The release said the greatest lean-mass reductions occurred during the first six months, the period of fastest weight loss.
A predefined MRI substudy assessed fat-free thigh muscle volume. At week 52, participants on semaglutide plus placebo had an average decline of 1.03 units. Declines were 0.29 units with 25 mg of trevogrumab and 0.32 units with 75 mg, corresponding to 71.8% and 68.9% preservation, respectively.
Trevogrumab did not meaningfully increase weight loss beyond that achieved with semaglutide alone, according to the company.
Among participants receiving lower-dose trevogrumab, 77% reported at least one adverse event, compared with 82% in the placebo group. The most common events were nausea, constipation, diarrhea and vomiting. Trevogrumab has not been evaluated for safety or efficacy by regulatory authorities.
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