Veru has reported promising results from its phase 2b QUALITY trial investigating enobosarm as a muscle-preserving complement to GLP-1 agonist therapy, though market response remained skeptical. The study focused on addressing a critical concern in obesity treatment: the loss of lean muscle mass during weight loss, particularly in older adults.
The trial demonstrated that overweight or obese patients aged 60 and older who received enobosarm in combination with Novo Nordisk's Wegovy (semaglutide) experienced 71% less lean mass loss compared to those on Wegovy alone, marking a statistically significant improvement in muscle preservation.
Physical Function Benefits
The study revealed notable improvements in functional capacity, with 54.5% fewer patients in the enobosarm group experiencing significant decline in stair-climbing ability - defined as a 10% or greater reduction from baseline. This functional benefit has prompted Veru to designate stair climb ability as the primary endpoint for upcoming phase 3 trials.
Mixed Results on Fat Mass Reduction
While the combination therapy showed promise in muscle preservation, results were less definitive in other areas. The enobosarm group demonstrated 27% greater fat mass reduction compared to Wegovy monotherapy, though this difference did not reach statistical significance. Overall weight loss was comparable between the combination and Wegovy-only groups.
Expert Perspective
"Weight loss through any modality produces a loss of both lean and fat mass," explained Dr. Louis Aronne, a past president of the Obesity Society and advisor to Veru. "The greater magnitude of weight loss seen with bariatric surgery and [GLP-1 agonists] has produced an unmet medical need to preserve muscle and physical function in older patients receiving these treatments."
Market Response and Future Directions
Despite achieving its primary objective of muscle preservation, Veru's share price declined almost 48% following the announcement. This sharp market reaction may reflect both the competitive landscape in obesity treatment and investors' heightened expectations for new therapies in this space. The company noted that this represents the first human study examining a muscle preservation agent's effects on body composition in older patients undergoing GLP-1 agonist treatment for obesity.
Safety data from the trial remains blinded until April, with the company maintaining its commitment to advance enobosarm into phase 3 testing based on the positive functional outcomes observed.
