Veru Reports Positive Results from Phase 2b QUALITY and Maintenance Extension Study Showing Enobosarm Significantly Reduced Body Weight Regain, Prevented Fat Regain, and Preserved Lean Mass After Semaglutide Discontinuation

Core Insights - Veru Inc. announced positive topline efficacy and safety results from the Phase 2b QUALITY clinical study, particularly highlighting the effectiveness of enobosarm in weight management after discontinuing semaglutide treatment [1][15] - Enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo, while preserving lean mass [1][4] - The company has been granted a meeting with the FDA to discuss advancing enobosarm into Phase 3 clinical trials [1][15] Efficacy Results - In the placebo group, participants regained 43% of the body weight lost during the initial study phase after stopping semaglutide, while the enobosarm 3mg group regained only 1.41% (2.73 lbs) [1][4] - Enobosarm treatment resulted in up to 93% greater fat loss and 100% preservation of lean mass compared to the placebo group at the end of the study [1][4][6] - The enobosarm plus semaglutide regimen preserved 100% of lean mass, with 99% of body weight loss attributed to fat [2][5] Safety Profile - Enobosarm monotherapy maintained a positive safety profile with essentially no gastrointestinal side effects observed during the maintenance period [1][10] - There were no significant adverse events related to liver injury or increases in prostate-specific antigen levels, and no reports of suicidal ideation were noted [11][12] Study Design - The Phase 2b Maintenance Extension study involved 148 participants who discontinued semaglutide and received either placebo, enobosarm 3mg, or enobosarm 6mg for 12 weeks [3][15] - The study aimed to assess the role of enobosarm in preserving lean mass and preventing weight regain after stopping semaglutide [3][8] Future Outlook - The company anticipates reporting full Phase 2b QUALITY and Maintenance Extension clinical trial data at leading scientific conferences and in publications [2][15] - Enobosarm is positioned as a next-generation drug that enhances weight reduction by GLP-1 RA drugs, focusing on fat loss while preserving lean mass [14][15]