Patients taking Novo Nordisk’s Wegovy plus Veru’s enobosarm saw 71% lower lean mass loss than those who were taking Wegovy alone but investors await more data.
Veru Inc. on Monday unveiled topline data from its Phase IIb QUALITY study, demonstrating that its investigational selective androgen receptor modulator enobosarm can significantly improve the quality of weight-loss in seniors with obesity and overweight who were taking Novo Nordisk’s Wegovy.
After 16 weeks of follow-up, patients given enobosarm on top of Wegovy lost 71% less lean mass than counterparts who were only taking Wegovy. This effect was highly statistically significant, with a p-value of 0.002, according to the biotech’s news release. Participants taking enobosarm also saw a significant 27% greater fat loss than control.
However, there was no difference in weight loss, Truist Securities analysts pointed out in a note to investors, adding that this and safety are “key metrics investors are looking for.” They added that VERU shares were down about 50% in pre-market trading Monday despite the XBI remaining “flattish.”
“We await extension data from Veru later in 1H2025,” the Truist team wrote. “The extension part of the trial has been designed to show that treatment can maintain muscle and augment fat loss and will be evaluated by body composition.”
Veru CEO Mitchell Steiner has emphasize the importance of the quality of weight loss.
“Older patients who are overweight or have obesity and receiving only a Wegovy (semaglutide) GLP-1 RA are at higher risk for accelerated frailty and functional decline,” Veru CEO Mitchell Steiner said in a statement. “The potential for further reduction in physical function because of ongoing loss of lean mass with chronic GLP-1 RA therapy is worrisome and must be evaluated.”
Currently available GLP-1 agents “could cause significant loss of lean mass in older patients,” Steiner added, in turn potentially leading to worse mobility and balance, while also aggravating the risk of disability and functional limitations.
According to the newly released results, fewer patients taking enobosarm saw a 10% or greater decline in their stair climb power.
With these topline data from QUALITY, Veru will meet with the FDA to determine the best path forward for enobosarm, particularly to align on the design of its Phase III program, Steiner said.
Enobosarm is a daily pill that modulates the androgen receptor. Its development comes as the biopharma industry looks for ways to take the lucrative—but increasingly highly competitive—obesity market forward. Some players, like leaders Eli Lilly and Novo Nordisk, are working on next-generation obesity therapies that offer even greater weight loss or more convenient dosing.
Others, like Veru, are seeking to carve out their niches by targeting the quality of weight loss—that is, helping patients shed pounds specifically from fat mass, while preserving their muscle mass.
Joining Veru in this space is Regeneron, which in February 2024 announced that it would be advancing two muscle-sparing antibodies trevogrumab and garetosmab to be tested in combination with incretin-based weight loss medicines. However, only trevogrumab remains listed as an obesity asset in the pharma’s pipeline webpage.
Altimmune is also in the muscle-preserving game, with its investigational drug pemvidutide eliciting strong weight reduction that was more than 71% attributable to fat loss. More recently, Lilly in November 2024 entered into a partnership with Chinese biotech laekna to advance an antibody that induces weight-loss while also preserving muscle mass.
Editor’s note (Jan. 27): This story has been updated to include commentary from Truist Securities analysts.
