Veru’s enobosarm meets primary endpoint in Phase 2b weight reduction trial

Veru (VERU) announced positive topline results from the Phase 2b QUALITY clinical study. The Phase 2b QUALITY clinical study was placebo-controlled dose-finding study to evaluate the safety and efficacy of enobosarm 3mg, and enobosarm 6mg, vs. placebo in 168 older patients, greater than 60 years of age, who are overweight or have obesity and who are receiving WEGOVY, a GLP-1 receptor agonist, for weight reduction. The primary endpoint was the change in total lean body mass from baseline to 16 weeks, and key secondary endpoints were the change from baseline to 16 weeks in total fat mass, total body weight, and physical function as measured by a stair climb test. The Phase 2b QUALITY clinical study met its primary endpoint with a statistically significant benefit in preservation of total lean body mass in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks. Secondary endpoints showed: enobosarm + semaglutide treatment resulted in a greater reduction in total fat mass compared to placebo + semaglutide at 16 weeks; there appears to be minor differences in total body weight changes between the enobosarm + semaglutide group and placebo + semaglutide group at 16 weeks. Therefore, enobosarm + semaglutide improved changes in body composition and resulted in more selective and greater loss of fat mass than in subjects receiving placebo + semaglutide. The proportion of subjects that lost greater than or equal to10% stair climb power was statistically significant and clinically meaningfully reduced in the enobosarm + semaglutide groups compared to placebo + semaglutide group. Therefore, enobosarm reduced the proportion of patients that lost clinically significant physical function versus subjects receiving semaglutide alone. Safety data remains blinded in the ongoing clinical study and the unblinded safety set will be available when the Phase 2b extension study is done in April 2025. However, the aggregate, blinded data, have not shown significant differences compared to different previous studies of enobosarm.