Veru has announced the first patient enrolment in its Phase IIb PLATEAU study assessing the combination of enobosarm, an oral selective androgen receptor modulator (SARM), and semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1) drug for obesity in older adults.
The placebo-controlled, double-blind trial will evaluate enobosarm 3mg’s impact on total body weight, lean mass, fat mass, bone mineral density, physical function, and safety.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It will include around 200 participants aged 65 years or older with a body mass index (BMI) of at least 35 who are starting semaglutide therapy for weight reduction.
The trial seeks to address the common weight loss plateau experienced by patients receiving semaglutide by adding enobosarm to help preserve muscle mass and physical function.
The main outcome is the percentage change from baseline in total body weight at 68 weeks. An interim analysis at 34 weeks will assess changes in lean body mass and fat mass using DXA scans.
Key secondary endpoints for the study include changes in total fat mass, total lean mass, physical function using the stair climb test, bone mineral density, and patient-reported outcomes for HbA1c, physical function and insulin resistance.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe selection of semaglutide builds on Veru’s earlier positive data from its Phase II QUALITY study combining enobosarm with semaglutide.
The trial data with injectable semaglutide may support future studies combining oral formulations of both drugs for broader clinical application.
Pennington Biomedical Research Center Body Composition-Metabolism Laboratory director Steven Heymsfield is the principal investigator and also led Veru’s Phase II QUALITY study.
An interim analysis is planned at 34 weeks, with results expected in the first quarter of 2027; final topline data are anticipated by the fourth quarter of 2027.
Veru chairman, president and CEO Mitchell Steiner said: “There is a significant unmet medical need for a combination therapy to enable the vast majority of patients to break through the weight loss plateau observed with current weight reduction therapies, particularly for those patients who sadly still have clinical obesity at the time they reach this weight loss plateau where they are no longer able to lose any more weight.
“Veru is convinced that the strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 receptor agonists for patients to maximise fat loss, while preserving lean mass and physical function and increasing bone mineral density for the highest quality weight reduction.”
