Veru Starts 200-Patient Phase 2b Trial of Enobosarm-Semaglutide Combo
Veru Inc. has enrolled the first of approximately 200 patients aged 65+ (BMI ≥35) in its Phase 2b PLATEAU trial assessing 3mg enobosarm plus semaglutide for enhanced fat loss and lean mass preservation. An interim analysis on lean body and fat mass is due Q1 2027, with topline results expected Q4 2027.
1. Trial Initiation
Veru Inc. has enrolled the first patient in its double-blind, placebo-controlled Phase 2b PLATEAU study, targeting roughly 200 older adults (aged ≥65 years) with obesity (BMI ≥35). The trial administers oral enobosarm 3mg alongside semaglutide to evaluate combined effects on weight and body composition.
2. Study Design and Endpoints
The primary endpoint is percent change from baseline in total body weight at 68 weeks. A planned interim analysis at 34 weeks will assess lean body mass and fat mass via DXA scans, with additional secondary measures including physical function tests, bone mineral density, HbA1c, and insulin resistance.
3. Strategic Rationale
Veru aims to overcome the weight loss plateau seen with GLP-1 receptor agonists by adding enobosarm to preserve muscle and enhance fat reduction. Positive Phase 2 QUALITY data supports moving into the PLATEAU trial as a precursor to a future Phase 3 combination therapy program.