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Clinical trials have demonstrated weight loss ranging from approximately 10% with GLP-1 agents at weight management doses (e.g., semaglutide 2.4 mg in the STEP trials) to over 20% with tirzepatide at higher doses (SURMOUNT trials)

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The FDA's pediatric drug development guidance specifically requires dedicated pediatric pharmacokinetic studies before dosing recommendations can be made for new molecular entities in patients under 18 [16]

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