Interim analysis is expected in Q1 2027, with final topline data due in Q4 2027 for enobosarm plus semaglutide in older patients with obesity.
Veru said it has completed enrollment above the targeted roughly 200 patients in its Phase 2b PLATEAU study, which is testing oral enobosarm 3 mg against placebo in older patients with obesity who are starting semaglutide for weight reduction. The double-blind, placebo-controlled trial is evaluating total body weight, fat mass, lean mass, physical function, bone mineral density and safety in patients age 65 and older with BMI of at least 35. The company expects an interim analysis in the first quarter of calendar 2027 and final topline clinical data in the fourth quarter of calendar 2027. The study is designed to test whether enobosarm can help address the weight-loss plateau sometimes seen with GLP-1 RA (GLP-1 receptor agonist) treatment by preserving muscle mass and physical function, with a primary endpoint of percent change from baseline in total body weight at 68 weeks. Key secondary endpoints include fat mass, lean mass, stair climb performance, mobility disability assessment, bone mineral density, patient-reported physical function, HbA1c and insulin resistance. Veru said a 32-week interim look will assess lean body mass and fat mass using DXA (bone and body composition scan). Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc., called the enrollment milestone important for developing enobosarm as a potential next-generation combination therapy with GLP-1 receptor agonists in older patients with obesity. Veru also pointed to its completed Phase 2b QUALITY study and maintenance extension, which it described as positive, saying enobosarm plus semaglutide preserved lean mass and physical function, increased fat loss during the 16-week active weight-loss period, and that enobosarm monotherapy prevented regained weight after the GLP-1 RA was stopped. In June 2026, Veru announced a clinical supply agreement with Novo Nordisk for the PLATEAU study. The company said enobosarm is an oral selective androgen receptor modulator, or SARM (drug targeting androgen receptors), while sabizabulin, another late-stage candidate, is being developed for chronic inflammation related to atherosclerotic cardiovascular disease.