Veru Reports Positive Safety Results from Phase 2b QUALITY Study: Enobosarm Added to Semaglutide Led to Greater Fat Loss, Preservation of Muscle, and Fewer Gastrointestinal Side Effects Compared to Semaglutide Alone
--Phase 2b QUALITY clinical study topline safety data shows that the enobosarm + semaglutide combination had a positive safety profile compared to semaglutide alone--
--Based on Phase 2b QUALITY trial efficacy and safety data, enobosarm 3mg will advance as the proposed oral dose for the Phase 3 clinical program----Enobosarm 3mg + semaglutide combination had the added benefit of fewer gastrointestinal side effects (Diarrhea, Nausea, and GERD) compared to semaglutide alone--
--Enobosarm 3mg added to semaglutide resulted in the highly selective loss of fat mass, accounting for 99% of the total weight lost, while preserving lean mass--
--With this positive Phase 2b QUALITY study, Veru has requested an End of Phase 2 meeting with FDA to provide regulatory clarity on the Phase 3 clinical program--
--The topline efficacy and safety data for the Phase 2b extension maintenance study to assess whether enobosarm monotherapy prevents the fat and weight regain following discontinuation of semaglutide are expected in the second quarter--
MIAMI, FL, May 28, 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 safety results from the Phase 2b QUALITY clinical study, a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial, designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to enhance fat loss and to prevent muscle loss in older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management.
Positive Topline Safety Results for the Phase 2b QUALITY Clinical Trial
Adverse events (AEs) and adverse events of special Interest (see table below).In the Phase 2b QUALITY clinical trial, enobosarm and semaglutide GLP-1 RA combination had a positive safety profile. There were no increases in gastrointestinal side effects, no evidence of drug-induced liver injury (as defined by Hy’s law), and no increases in obstructive sleep apnea at any dose of enobosarm compared to placebo (semaglutide alone). There were no AEs of increases in prostate specific antigen in men. There were no AEs related to masculinization in women. There were no reports of suicidal ideation observed (Columbia-Suicide Severity Rating Scale). No treatment related serious adverse events (SAEs) were observed in the QUALITY study. There were 4 non-treatment related SAEs equally distributed between the treatment groups.
At the proposed Phase 3 clinical program dose of enobosarm 3mg, one subject experienced an adverse event of transient, mild increase in alanine aminotransferase (ALT), which returned to baseline while remaining on enobosarm. There were no accompanying increases in aspartate aminotransferase (AST), alkaline phosphatase or total bilirubin. The enobosarm 3mg + semaglutide group had the added benefit of fewer AEs reported for certain gastrointestinal side effects (Diarrhea, Nausea, and Gastroesophageal Reflux Disease) compared to placebo + semaglutide.
“The safety results from the Phase 2b study are positive and suggest that the addition of enobosarm to semaglutide treatment doesn’t worsen, and in some cases appears to improve gastrointestinal side effects”, said Louis J. Aronne, MD, an obesity expert, past president of the Obesity Society and a scientific advisor and consultant to Veru.
Topline Phase 2b QUALITY clinical trial safety summary: Adverse Events1 and Adverse Events of Special Interest
| Placebo+Semaglutiden=56 | Enobosarm 3mg+Semaglutiden=56 | Enobosarm 6mg+Semaglutiden=56 | |
| Nausea | 11 (20%) | 6 (11%) | 8 (14%) |
| Gastroesophageal Reflux Disease (GERD) | 7 (13%) | 3 (5%) | 0 (0%) |
| Diarrhea | 4 (7%) | 1 (2%) | 7 (13%) |
| Vomiting | 2 (4%) | 1 (2%) | 4 (7%) |
| Constipation | 8 (14%) | 7 (13%) | 6 (11%) |
| Alanine aminotransferase (ALT) increased | 0 (0%) | 1 (2%)2 | 6 (11%)3 |
| Aspartate aminotransferase (AST) increased | 0 (0%) | 0 (0%) | 1 (2%)3 |
| Obstructive sleep apnea syndrome | 9 (16%) | 10 (18%) | 11 (20%) |
| Upper respiratory tract infection | 1 (2%) | 1 (2%) | 4 (7%) |
| Headache | 2 (4%) | 4 (7%) | 1 (2%) |
| Fatigue | 2 (4%) | 0 (0%) | 4 (7%) |
1 Adverse events (at least 4 subjects in any dose group) from Day 1 to Day 1122 Graded as mild in severity, levels returned to below baseline while on drug, no associated increase in alkaline phosphatase or total bilirubin3 All graded as mild in severity, all returned to or toward baseline/upper limit of normal, no associated increases in alkaline phosphatase or total bilirubin
“We previously shared positive results from the Phase 2b QUALITY study, indicating that enobosarm can selectively enhance fat loss while preserving lean mass and physical function in older patients using semaglutide for weight loss. Today, we announced that the topline safety data from the Phase 2b QUALITY clinical study confirms that enobosarm has a positive safety profile with the added benefit of reducing certain gastrointestinal side effects that patients commonly experience with semaglutide and other GLP-1 receptor agonists. Based on these efficacy and safety results, the enobosarm 3mg dose has been selected to advance into our proposed Phase 3 study,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “We have submitted a request for an End of Phase 2 meeting with FDA, which we anticipate will take place in the third quarter of calendar year 2025. The meeting is expected to provide regulatory clarity on the design of our planned Phase 3 clinical program. Further, we are expecting the topline efficacy and safety results for the Phase 2b extension maintenance study this quarter, which will show us whether enobosarm monotherapy can stop the fat and weight regain that generally happens when patients discontinue GLP-1 receptor agonist treatment. Finally, we look forward to reporting the full Phase 2b QUALITY and extension clinical trial efficacy and safety data at future leading scientific conferences and in prestigious publications.”
Positive Topline Efficacy Results for the Phase 2b QUALITY Clinical Study: Enobosarm in Combination with GLP-1 RA Drugs Makes Weight Reduction More Tissue Selective for Fat Loss While Preserving Lean Mass and Physical Function
In January 2025, the Company announced positive topline results from the Phase 2b QUALITY clinical study, which is a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management.
Topline Efficacy Results
Topline Primary Endpoint – Percent Change in Total Lean MassIn the topline efficacy analysis, the trial met its prespecified primary endpoint with a statistically significant and a clinically meaningful benefit in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks in total lean mass (71% relative reduction in lean mass loss, p=0.002). Notably, the enobosarm 3mg + semaglutide was the best dose with a 99.1% mean relative reduction in loss of lean mass (p
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