Core Insights - The Phase 2b QUALITY clinical study demonstrated that the combination of enobosarm and semaglutide has a positive safety profile, with fewer gastrointestinal side effects compared to semaglutide alone [1][3][4] - Enobosarm 3mg has been selected as the proposed oral dose for the upcoming Phase 3 clinical program based on the efficacy and safety data from the Phase 2b trial [1][8] - The combination treatment resulted in a highly selective loss of fat mass, with 99% of total weight lost attributed to fat, while preserving lean mass [1][14] Safety Profile - The Phase 2b QUALITY clinical trial showed no increases in gastrointestinal side effects or drug-induced liver injury compared to placebo [3][4] - Adverse events related to gastrointestinal issues were lower in the enobosarm + semaglutide group compared to the placebo + semaglutide group [4][6] - No serious adverse events related to treatment were observed, and all reported adverse events were mild and returned to baseline levels [3][4][6] Efficacy Results - The trial met its primary endpoint with a statistically significant reduction in lean mass loss, showing a 71% relative reduction in lean mass loss for enobosarm + semaglutide compared to placebo + semaglutide [9][14] - Enobosarm 3mg + semaglutide showed a 99.1% mean relative reduction in lean mass loss, while the 6mg dose did not provide additional benefits [9][11] - The treatment also demonstrated a significant reduction in the percentage of patients experiencing a decline in stair climb power, indicating improved physical function [17] Regulatory Steps - Following the positive results from the Phase 2b study, the company has requested an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program [1][16] - The proposed Phase 3 study will be a double-blind, placebo-controlled trial focusing on older patients with obesity or overweight, assessing the effects of enobosarm on physical function and body composition [19][20] Future Developments - The company is developing a novel modified release oral formulation of enobosarm, expected to enter Phase 1 bioavailability clinical trials in early 2025 [21] - The new formulation aims to be available for Phase 3 clinical studies and commercialization, with patent protection anticipated until 2045 [21]