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Key FDA guidance: Incremental weight loss (enobosarm + GLP-1 versus GLP-1 alone) is an acceptable primary endpoint for approval The 3 mg dose is appropriate for continued development FDA encouraged including younger patients, not just older populations Phase 2 QUALITY study data: 16 weeks of enobosarm in older patients taking semaglutide Preserved lean mass and burned additional fat mass Improved physical function During the maintenance period (12 weeks after semaglutide discontinuation), enobosarm prevented weight regain by 46% compared to placebo Next steps : Veru plans to initiate the Phase 2b PLATEAU trial in Q1 2026, enrolling approximately 180 patients (both older and younger) with obesity taking tirzepatide

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