Veru Reports Positive Results from Phase 2b QUALITY and Maintenance Extension Study Showing Enobosarm Significantly Reduced Body Weight Regain, Prevented Fat Regain, and Preserved Lean Mass After Semaglutide Discontinuation
During the Maintenance Period of 12 weeks after discontinuing semaglutide (GLP-1 receptor agonist), placebo group regained 43% of body weight that was previously lost during Phase 2b QUALITY study; on average, enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo--
--The enobosarm treated groups showed up to 93% greater fat loss and 100% lean mass preservation compared to the placebo group at the end of the study--
--Enobosarm monotherapy had a positive safety profile with essentially no gastrointestinal side effects during the maintenance treatment period--
-- Based on efficacy and safety from Phase 2b QUALITY and Maintenance Extension study:
--Enobosarm 3mg will advance as the proposed oral dose for the Phase 3 clinical program--
--Veru has been granted a meeting with FDA to discuss the Phase 3 clinical program--
MIAMI, FL, June 24, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced positive topline efficacy and safety results from the maintenance extension portion of the Phase 2b QUALITY clinical study. The Phase 2b Maintenance Extension clinical trial demonstrated that in 12 weeks after stopping semaglutide, the placebo monotherapy group regained 43% of body weight that was previously lost during the Phase 2b QUALITY study, while enobosarm monotherapy reduced weight regain by 46% in the enobosarm 3mg group and completely prevented fat regain and preserved lean mass in both enobosarm dose groups compared to placebo after semaglutide discontinuation. Enobosarm treatment also led to up to 93% greater loss of fat mass and 100% preservation of lean mass compared to the placebo group at the end of the study. Enobosarm monotherapy maintained a positive safety profile, with essentially no gastrointestinal side effects observed during the maintenance period.
“Based on our Phase 2b QUALITY active weight loss portion of the study, enobosarm 3mg preserved 100% of lean mass, 99% of body weight loss was from fat, and preserved physical function as measured by stair climb test, when combined with a GLP-1 drug compared to placebo. The Maintenance Extension portion of the study shows that if you stop a GLP-1 drug, you can preserve lean mass, blunt the regain of fat and weight, and keep off the fat you lost when you remain on enobosarm monotherapy. Enobosarm provides a compelling option for patients that would like to maintain their weight loss and fat loss after discontinuing semaglutide, regardless of whether such discontinuation was by choice or by necessity,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “We look forward to reporting the full Phase 2b QUALITY and Maintenance Extension clinical trial efficacy and safety data at future leading scientific conferences and in publications.”
“I am pleased to see both muscle preservation and improvement in physical function with enobosarm when given with semaglutide, a GLP-1 medication.
Veru Reports Positive Results from Phase 2b QUALITY and |
