Veru Inc. ( VERU ) stock is plummeting on Monday after the company released topline results from the Phase 2b QUALITY clinical study of enobosarm for weight reduction.

The study evaluates the safety and efficacy of enobosarm 3mg and enobosarm 6mg, compared to placebo in 168 older patients, greater than 60 years of age, who are overweight or have obesity and who are receiving Novo Nordisk A/S’ Wegovy (semaglutide).

The primary endpoint was the change in total lean body mass, and key secondary endpoints were the change from baseline to 16 weeks in total fat mass, total body weight, and physical function as measured by a stair climb test.

The study met its primary endpoint with a statistically significant benefit in preservation of total lean body mass in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks.

Secondary endpoints showed:

On average, patients on Enobosarm + semaglutide treatment lost 71% less lean mass than patients receiving Wegovy alone.

Patients on Enobosarm + semaglutide treatment on average lost 27% more fat mass than patients receiving Wegovy alone.

There appear to be minor differences in total body weight changes between the enobosarm+semaglutide group and placebo+semaglutide group at 16 weeks. Therefore, enobosarm+semaglutide improved changes in body composition and resulted in more selective and greater fat mass loss than in subjects receiving placebo + semaglutide.

The proportion of subjects who lost ≥10% stair climb power was statistically significant and clinically meaningfully reduced in the enobosarm + semaglutide groups compared to the placebo + semaglutide group.

Therefore, enobosarm reduced the proportion of patients who lost clinically significant physical function compared to subjects receiving semaglutide alone.

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Safety data remains blinded in the ongoing clinical study and the unblinded safety set will be available when the Phase 2b extension study is done in April 2025.

The Phase 2b extension trial is ongoing in which all patients stop receiving a GLP-1 RA but continue taking a placebo, enobosarm 3mg or enobosarm 6mg, for an additional 12 weeks.

The Phase 2b extension study will evaluate the maintenance of weight loss, meaning whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA.

Price Action: Veru ( VERU ) stock is down 48.5% at 62 cents last check Monday.

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