Veru Completes Enrollment in Phase 2b PLATEAU Trial of Enobosarm and Semaglutide, Advances Obesity Programme Targeting Muscle Preservation

Veru Inc. has completed enrollment in its Phase 2b PLATEAU clinical trial, which is evaluating oral enobosarm 3 mg alongside semaglutide in approximately 200 older adults aged 65 and above living with obesity. The study is designed to assess whether enobosarm can improve the quality of weight loss by helping preserve lean muscle mass and physical function while supporting additional reductions in body weight and fat mass.

The double-blind, placebo-controlled trial is enrolling patients with a BMI of at least 35 who are starting semaglutide treatment for weight reduction. Researchers will assess changes in total body weight, fat mass, lean mass, physical function, bone mineral density, and safety. The primary efficacy measure is the percentage change in total body weight after 68 weeks, while secondary measures include fat and lean mass, stair-climbing performance, mobility, bone density, physical function, HbA1c, and insulin resistance.

“We are extremely pleased to have expeditiously completed enrollment in the Phase 2b PLATEAU clinical trial, which marks an important milestone in the development of enobosarm as a potential next generation combination therapy with GLP-1 receptor agonists for older patients with obesity,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “There remains a significant unmet medical need in older patients with obesity who are more likely to have low muscle reserves to make weight reduction more tissue selective by maximizing fat loss while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction. Retaining muscle and preserving physical function burns more fat potentially enabling patients to break through the weight loss plateau to have greater weight reduction.”

The PLATEAU study is intended to investigate whether enobosarm can help address the weight-loss plateau associated with GLP-1 receptor agonist treatment by preserving muscle and physical function, potentially enabling further clinically meaningful weight reduction. An interim analysis focused on lean and fat mass, measured using DXA scans after 32 weeks, is expected in the first quarter of 2027, with final topline results anticipated in the fourth quarter of 2027. In June 2026, Veru also announced a clinical supply agreement with Novo Nordisk to support the PLATEAU study.

Dr. Steiner added: “Achieving greater than full enrollment across the study sites reflects the dedication of patients, investigators, healthcare professionals, and the Veru team. This accomplishment advances our mission to make the weight loss process as healthy as it can be, benefiting patients and making their lives better.”

The programme builds on results from Veru's completed Phase 2b QUALITY trial, which evaluated enobosarm in older patients receiving semaglutide for weight loss. The study found that combining enobosarm with semaglutide helped preserve lean mass and physical function while producing greater fat loss during the active 16-week treatment period. A subsequent maintenance extension also indicated that enobosarm monotherapy helped prevent the regain of weight after semaglutide treatment was discontinued, providing further support for the company's strategy of developing enobosarm as a potential complementary treatment for obesity.