Veru's Enobosarm Shows Muscle In Wegovy Combo Trial

Penny stock Veru Inc. VERU on Wednesday released topline safety results from the Phase 2b QUALITY study of enobosarm 3mg, enobosarm 6mg, or placebo to enhance fat loss and prevent muscle loss in patients over 60 years receiving Novo Nordisk A/S’ NVO Wegovy (semaglutide) for chronic weight management.

The enobosarm and semaglutide GLP-1 RA combination had a favorable safety profile in the trial.

Also Read: Veru Shares Tumble Despite Enobosarm’s Lean Muscle Preservation Breakthrough

There were no increases in gastrointestinal side effects. There is also no evidence of drug-induced liver injury, or increases in obstructive sleep apnea at any dose of enobosarm compared to the placebo.

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.

No treatment-related serious adverse events (SAEs) were observed in the QUALITY study.

At the proposed Phase 3 program dose of enobosarm 3mg, one subject experienced an adverse event of a 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 data shows that adding enobosarm 3mg to semaglutide created a more selective weight loss profile, with 99.1% of weight loss coming from fat rather than muscle compared to 68% in the semaglutide plus placebo arm.

The Stair Climb Test showed that 42.6% of semaglutide-only patients experienced significant functional decline equivalent to 7.5 years of aging, while only 16% of the enobosarm 3mg combination group showed a similar decline, translating to a 62.4% relative reduction in functional deterioration.

The enobosarm 6mg + semaglutide dose did not provide any additional benefit over the 3mg dose in preserving lean mass.

The company plans to propose a Phase 3 program similar to the Phase 2b QUALITY trial in older patients. The GLP-1 RA may be either Wegovy and/or Eli Lilly And Co’s LLY Zepbound (tirzepatide).

Price Action: VERU stock is up 22.5% at 62 cents at the last check Wednesday.

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