Enobosarm with semaglutide (Wegovy) - (PLATEAU)

July 27, 2026: Veru Inc. (NASDAQ: VERU) reported completing enrollment (exceeding the targeted ~200 patients) in its Phase 2b PLATEAU trial evaluating oral enobosarm 3 mg vs placebo in older adults (≥65; BMI ≥35) with obesity who are initiating semaglutide for weight reduction. PLATEAU is double-blind and placebo-controlled, assessing effects on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety through 68 weeks; the primary endpoint is percent change in total body weight at 68 weeks, with key secondary endpoints including DXA-measured fat/lean mass, stair climb test, mobility disability assessment, bone mineral density, patient-reported outcomes, HbA1c, and insulin resistance. An interim analysis (DXA lean and fat mass after 32 weeks) is expected in calendar Q1 2027; final topline data are expected in calendar Q4 2027. The release also notes a June 2026 clinical supply agreement with Novo Nordisk to supply semaglutide/Wegovy for PLATEAU.

Veru also summarized its completed Phase 2b QUALITY study (168 patients ≥60) as positive, stating enobosarm (3 mg or 6 mg) plus semaglutide preserved lean mass and physical function and increased fat loss over 16 weeks, and that enobosarm monotherapy in a 12-week extension prevented weight regain after semaglutide discontinuation.