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The regulation itself states that available data are inadequate to demonstrate the safety or efficacy of any drug product compounded using the substances listed there, or to establish general recognition of safety or effectiveness
[5] [6] Early-phase clinical trials including a Phase 2 trial published in the New England Journal of Medicine (2023) have reported significant reductions in body weight and improvements in metabolic markers, though this evidence remains preliminary and is not sufficient to establish a clinical dosing or reconstitution standard
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