Veru (NASDAQ:VERU) has announced positive topline results from its Phase 2b QUALITY clinical study evaluating the safety and efficacy of enobosarm in patients receiving WEGOVY (semaglutide) for weight reduction.
According to Veru, the study met its primary endpoint: enobosarm treatment led to a statistically significant reduction in lean mass loss among patients receiving WEGOVY. Patients treated with enobosarm lost, on average, 71% less lean mass and 27% more fat mass compared to those receiving WEGOVY alone. Furthermore, the company reports that enobosarm improved body composition, as the mean total body weight loss was comperable to patients receiving WEGOVY alone. Enobosarm also reduced the proportion of patients who experienced significant physical function loss compared to WEGOVY alone.
In a statement, Mitchell Steiner, MD, chairman, president, and CEO of Veru, said, “Given the promising topline results from the Phase 2b QUALITY clinical trial where enobosarm treatment preserved lean mass, increased fat loss, improved body composition changes, and prevented decline in stair climb physical function in patients receiving WEGOVY, we plan to meet with FDA to discuss the design of the Phase 3 clinical program.”
Dr. Steiner added, “The Phase 2b QUALITY study is the first human study to demonstrate that older patients who are overweight or have obesity and receiving only a WEGOVY GLP-1 RA are at higher risk for accelerated frailty and functional decline. Lean mass loss in the semaglutide group that did not receive enobosarm was significant as 32% of the total weight loss at 16 weeks was made up of lean mass. Loss of lean mass also matters as 42.6% of patients on placebo + semaglutide had at least a 10% decline in stair climb power. 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. The expectation is that all GLP-1 RA containing drugs could cause significant loss of lean mass in older patients raising concerns for potential declines in physical function, mobility disability, functional limitations, and loss of balance with a higher risk for falls and fractures.”
