Veru Enrolls First Patient in Phase 2b PLATEAU Trial of Enobosarm Plus Semaglutide

Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, announced that it has enrolled the first patient in its Phase 2b PLATEAU clinical trial of enobosarm, an oral selective androgen receptor modulator (SARM), to preserve muscle and physical function and to augment fat and weight loss when combined with semaglutide (Wegovy®), a Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drug, for potentially higher quality and quantity of weight loss in older patients with obesity. An interim analysis is expected in the first quarter of calendar year 2027, with final topline clinical data expected in the fourth quarter of calendar year 2027.

The company's Chairman, President, and Chief Executive Officer stated 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 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 maximize fat loss, while preserving lean mass and physical function and increasing bone mineral density for the highest quality weight reduction.

Veru's Phase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in approximately 200 older patients (age ≥ 65 years) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving semaglutide treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction.

The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 34 weeks to assess the percent change from baseline in lean body mass and fat mass, as measured by DXA scan. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance.

Semaglutide was selected as the GLP-1 RA for the Phase 2b PLATEAU study to build on Veru's previous clinical experience using enobosarm in combination with semaglutide in the positive Phase 2 QUALITY clinical study. Further, the clinical data from the Phase 2b PLATEAU clinical trial using injectable semaglutide should support the use of oral semaglutide in combination with oral enobosarm in future Phase 3 clinical studies. In contrast, tirzepatide injectable does not have an oral formulation.

The Principal Investigator for the Phase 2b PLATEAU clinical trial is a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana, who was also the Principal Investigator of Veru's Phase 2 QUALITY clinical study.

The Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the 16 week active weight loss period.