Semaglutide, Antibody Combination Protects Lean Mass During Weight Loss
Results from a phase 2 trial showed that semaglutide combined with trevogrumab, with or without garetosmab, helped patients preserve lean mass and achieve greater fat loss.
Positive interim results have been announced from a phase 2 trial evaluating the efficacy and safety of trevogrumab and garetosmab in combination with semaglutide for the treatment of obesity in adult patients, Regeneron announced in a release.1 The company said the full set of data will be available later this year.
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Data from the phase 2 COURAGE (NCT06299098) trial showed that combining semaglutide with trevogrumab, with or without garetosmab, helped to preserve lean mass while increasing the amount of fat loss. The semaglutide and trevogrumab combination was seen to be generally well tolerated among patients in the trial.
“Recent advancements have resulted in patients being able to lose significant amounts of body weight,” said George D Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, in a release.1 Unfortunately, this weight loss comes at the cost of muscle loss, and we know muscle is important to overall health.”
Semaglutide and other glucagon-like peptide-1 (GLP-1) receptor agonists have been shown to significantly help patients with obesity lose weight. However, negative impacts on lean body mass are more prevalent during significant weight reductions and can negatively impact patient outcomes. Maintaining lean mass during weight loss is important because it facilitates a higher metabolic rate and makes it easier to lose and maintain body weight.2
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COURAGE is a randomized, double-blind phase 2 trial evaluating the efficacy and safety of trevogrumab and garetosmab in combination with semaglutide for the treatment of obesity. The study cohort includes nearly 1000 adult patients between the ages of 18 and 80 years with a BMI between 18 and 32 kg/m2 at initial screening.
The study included 3 different parts. In part A, investigators assessed the safety and tolerability of trevogrumab and garetosmab in healthy patients. In parts B and C, investigators assessed the efficacy and safety of trevogrumab and garetosmab in combination with semaglutide in patients with obesity. Treatment was divided into 2 26 week periods, including a weight loss phase and a weight maintenance phase.
During the weight loss phase, patients randomly received semaglutide alone or in combination with a high or low dose of trevogrumab, or a high dose of trevogrumab and garetosmab. At the interim analysis, the study found that 34.5% of weight loss from semaglutide was due to the loss of lean mass. In all of the combination groups, patients preserved more lean mass and achieved greater fat loss compared to semaglutide alone.
Additionally, although semaglutide combined with trevogrumab was generally well-tolerated among patients, there was a high rate of treatment discontinuation due to tolerability issues and other adverse events among patients who received the semaglutide, trevogrumab and garetosmab combination.
“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,” Yancopoulos said in the release.1 “The full data set will be available later this year and will provide further insights to help optimize the dosing regimens in future trials.”
READ MORE: Obesity Management Resource Center
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