Miami, Florida, August 10, 2026
Veru Inc. has announced full enrollment of 239 patients in its Phase 2b PLATEAU clinical trial evaluating enobosarm in combination with semaglutide for higher-quality weight loss in older adults with obesity. The company originally targeted enrollment of 200 patients, making the completion ahead of the target a key clinical development milestone. The double-blind, placebo-controlled Phase 2b study is evaluating whether enobosarm can help patients receiving GLP-1 receptor agonist therapy achieve greater fat loss while preserving lean muscle mass, physical function and bone mineral density. The study is enrolling patients aged 65 years and older with obesity who are initiating semaglutide treatment. The primary endpoint is the percentage change in total body weight at Week 68, while secondary measures include fat mass, lean mass, physical function, mobility, bone mineral density, HbA1c and insulin resistance.
PLATEAU Trial Targets Higher-Quality Weight Loss
The PLATEAU clinical trial is designed to address a growing challenge associated with pharmacological weight loss: reducing body weight while maintaining muscle and physical function. Participants receive enobosarm 3 mg alongside semaglutide, with the study assessing whether the combination can overcome the weight-loss plateau that may occur during GLP-1 receptor agonist treatment. An interim analysis evaluating lean body mass and fat mass using DXA measurements is expected in the first quarter of 2027, after patients complete 32 weeks of treatment. Final topline results are currently expected in the fourth quarter of 2027. The company said the study has progressed rapidly following enrollment of 239 participants, exceeding its original target. Veru is developing enobosarm as a potential combination therapy intended to make GLP-1-based weight reduction more selective toward fat loss while helping preserve muscle and physical function.
Veru Strengthens Enobosarm Development and Patent Position
Veru also highlighted recent progress supporting the broader development of enobosarm for quality weight loss. In June 2026, the company entered into a clinical supply agreement with Novo Nordisk for the PLATEAU trial. In August, Veru received a U.S. Patent and Trademark Office Notice of Allowance for a patent covering enobosarm in combination with semaglutide and related treatment approaches. If issued, the patent is expected to provide U.S. protection until at least October 2044, before any potential patent term adjustment or extension. The company said the allowed claims cover approaches involving concurrent enobosarm and semaglutide treatment, adding enobosarm to existing semaglutide therapy, and using enobosarm after discontinuation of semaglutide. Veru’s intellectual property portfolio also includes additional patent applications covering enobosarm formulations and combinations with other weight-loss medicines.
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Financial Results and Next Clinical Milestones
For the fiscal 2026 third quarter ended June 30, Veru reported research and development expenses of $4.4 million, compared with $3.0 million in the prior-year period, while general and administrative expenses declined to $3.4 million from $5.0 million. Net loss decreased to $7.0 million, or $0.30 per share, compared with $7.3 million, or $0.50 per share, in the same period of fiscal 2025. Cash, cash equivalents and restricted cash totaled $23.9 million as of June 30, 2026. The company said its immediate clinical focus remains the PLATEAU program, with the interim analysis expected in Q1 2027 and final topline results anticipated in Q4 2027. Earlier Phase 2b QUALITY results showed that enobosarm combined with semaglutide preserved lean mass and physical function while supporting greater fat loss, providing the clinical rationale for the ongoing PLATEAU study. However, the larger Phase 2b trial will be important for determining whether those findings can be reproduced in a controlled study designed around longer-term weight and body-composition outcomes.
Source:Veru Inc. press release
