Veru Inc. VERU inventory is plummeting on Monday after the corporate launched topline outcomes from the Section 2b QUALITY medical examine of enobosarm for weight discount.
The examine evaluates the security and efficacy of enobosarm 3mg and enobosarm 6mg, in comparison with placebo in 168 older sufferers, higher than 60 years of age, who’re chubby or have weight problems and who’re receiving Novo Nordisk A/S’ NVO Wegovy (semaglutide).
The first endpoint was the change in whole lean physique mass, and key secondary endpoints had been the change from baseline to 16 weeks in whole fats mass, whole physique weight, and bodily perform as measured by a stair climb check.
The examine met its main endpoint with a statistically vital profit in preservation of whole lean physique mass in all sufferers receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks.
Secondary endpoints confirmed:
- On common, sufferers on Enobosarm + semaglutide remedy misplaced 71% much less lean mass than sufferers receiving Wegovy alone.
- Sufferers on Enobosarm + semaglutide remedy on common misplaced 27% extra fats mass than sufferers receiving Wegovy alone.
- There seem like minor variations in whole physique weight modifications between the enobosarm+semaglutide group and placebo+semaglutide group at 16 weeks. Due to this fact, enobosarm+semaglutide improved modifications in physique composition and resulted in additional selective and higher fats mass loss than in topics receiving placebo + semaglutide.
- The proportion of topics who misplaced ≥10% stair climb energy was statistically vital and clinically meaningfully diminished within the enobosarm + semaglutide teams in comparison with the placebo + semaglutide group.
- Due to this fact, enobosarm diminished the proportion of sufferers who misplaced clinically vital bodily perform in comparison with topics receiving semaglutide alone.
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Security information stays blinded within the ongoing medical examine and the unblinded security set might be accessible when the Section 2b extension examine is completed in April 2025.
The Section 2b extension trial is ongoing through which all sufferers cease receiving a GLP-1 RA however proceed taking a placebo, enobosarm 3mg or enobosarm 6mg, for an extra 12 weeks.
The Section 2b extension examine will consider the upkeep of weight reduction, which means whether or not enobosarm can keep muscle and stop the fats and weight achieve that happens after discontinuing a GLP-1 RA.
Worth Motion: Veru inventory is down 48.5% at 62 cents final examine Monday.
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