Veru completed enrollment in the Phase 2b PLATEAU trial evaluating enobosarm with semaglutide to preserve muscle during weight loss in older adults with obesity.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Veru Inc. has completed enrollment in the Phase 2b PLATEAU clinical trial evaluating oral enobosarm 3 mg in combination with semaglutide for weight management in older adults with obesity. The double-blind, placebo-controlled study has enrolled approximately 200 patients aged 65 years or older with a body mass index (BMI) of at least 35. Interim results are expected in the first quarter of 2027, while topline data are anticipated in the fourth quarter of 2027.
Scientific and Clinical Context
Enobosarm is an investigational selective androgen receptor modulator (SARM) that selectively activates androgen receptors in skeletal muscle and bone. The therapy is being developed to preserve lean body mass, maintain physical function, and support bone health during pharmacologic weight loss.
Although GLP-1 receptor agonists such as semaglutide have transformed obesity treatment, substantial weight loss often includes reductions in muscle mass alongside fat loss. Older adults are particularly vulnerable because they frequently have lower baseline muscle reserves and face a higher risk of frailty, impaired mobility, and reduced physical function. Preserving muscle during weight reduction may improve treatment quality and potentially enable additional fat loss after patients reach the weight loss plateau.
Phase 2b PLATEAU Trial Details
The PLATEAU study evaluates whether enobosarm can improve body composition and functional outcomes when added to semaglutide treatment over 68 weeks.
The primary endpoint is the percentage change in total body weight from baseline at Week 68. Key secondary endpoints include changes in total fat mass, lean body mass, physical function measured by the stair climb test, mobility disability, bone mineral density, glycated hemoglobin (HbA1c), insulin resistance, and patient-reported physical function outcomes.
An interim analysis will assess lean body mass and fat mass using dual-energy X-ray absorptiometry (DXA) after participants complete 32 weeks of treatment. Those findings are expected during the first quarter of 2027.
The trial follows Veru’s clinical supply agreement with Novo Nordisk, announced in June 2026, to support the PLATEAU study with semaglutide.
Building on Positive QUALITY Trial Findings
The PLATEAU study builds on encouraging results from Veru’s completed Phase 2b QUALITY trial (NCT06282458) involving 168 adults aged 60 years or older receiving semaglutide.
In that study, enobosarm at both 3 mg and 6 mg preserved lean muscle mass and physical function while enhancing fat loss during the initial 16-week active weight loss period. Participants then entered a 12-week maintenance extension after discontinuing semaglutide. During this phase, enobosarm monotherapy prevented weight regain that commonly occurs after GLP-1 receptor agonist discontinuation, supporting its potential role beyond active weight loss.
Clinical Implications
Mitchell Steiner, MD, Chairman, President, and Chief Executive Officer of Veru, said completing enrollment marks an important milestone in advancing enobosarm as a potential combination therapy for older adults with obesity. He noted that preserving muscle mass, physical function, and bone mineral density could improve the quality of weight reduction while enabling patients to sustain additional fat loss after reaching a weight loss plateau.
Steiner also credited the rapid enrollment to the commitment of patients, investigators, healthcare professionals, and study teams across participating clinical sites.
Path Forward
The PLATEAU trial advances Veru’s strategy to develop combination therapies that improve the quality of weight loss by preserving muscle while maximizing fat reduction. Positive results could support further clinical development of enobosarm as an adjunct to GLP-1 receptor agonists for older adults with obesity, a population at increased risk of muscle loss during weight reduction.
Reference
About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.