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This GRAS designation does not imply FDA approval for therapeutic, drug, or compounded use , and it is sometimes misrepresented in marketing copy
Whats the evidence
| Agent | FDA Approval | Mean Weight Loss (RCT) | Route | |---|---|---|---| | Semaglutide 2.4 mg (Wegovy) | Yes (2021) | 14.9% at 68 weeks (STEP-1, N=1,961) [9] | Subcutaneous weekly | | Tirzepatide 15 mg (Zepbound) | Yes (2023) | 20.9% at 72 weeks (SURMOUNT-1, N=2,539) [11] | Subcutaneous weekly | | AOD-9604 1 mg oral | No | ~2.8 kg at 12 weeks (Phase IIb, N=300 approx.) [1] | Oral (not currently compounded) | The weight-loss magnitude from the single Phase IIb AOD-9604 trial is substantially smaller than what STEP-1 (semaglutide) and SURMOUNT-1 (tirzepatide) demonstrated in larger, longer trials
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