Veru(VERU) Newsfilter·2025-01-27 11:30Core Insights - The Phase 2b QUALITY clinical study demonstrated that enobosarm treatment significantly reduced lean mass loss and improved fat mass loss in older patients receiving WEGOVY [1][4][6] - Enobosarm treatment preserved muscle mass and physical function, addressing a critical need in older patients undergoing weight loss treatments [6][10] Study Design - The Phase 2b QUALITY clinical study was a multicenter, double-blind, placebo-controlled trial involving 168 older patients over 60 years of age, who are overweight or obese and receiving WEGOVY [3][14] - The primary endpoint was the change in total lean body mass from baseline to 16 weeks, with key secondary endpoints including total fat mass, total body weight, and physical function [3][14] Topline Results - Enobosarm treatment resulted in a 71% reduction in lean mass loss compared to WEGOVY alone (p=0.002) [1][4] - Patients on enobosarm lost 27% more fat mass than those receiving WEGOVY alone, although this result was not statistically significant (p=0.096) [1][4] - The study found that 54.5% fewer patients on enobosarm experienced a ≥10% decline in stair climb power compared to those on placebo [4][8] Safety and Regulatory Steps - Safety data remains blinded, but previous studies indicate enobosarm is generally well tolerated with no significant gastrointestinal side effects [7][19] - The company plans to meet with the FDA to discuss the design of the Phase 3 clinical program based on the positive topline results [10][11] Future Directions - The ongoing Phase 2b extension study will evaluate whether enobosarm can maintain muscle and prevent weight gain after discontinuing GLP-1 RA [9][14] - The anticipated Phase 3 trial will focus on older patients receiving GLP-1 RA, with stair climb power as the primary objective [11][12]