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Eli Lilly submitted the orforglipron NDA to the FDA in Q1 2026 following ATTAIN Phase 3 trial data showing 14.7% body weight reduction at 45mg positioning the worlds first oral small molecule GLP-1 receptor agonist for obesity for anticipated FDA approval in late 2026 or 2027

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Any disagreements were resolved through consultation with a third reviewer (M.K.), who provided a final assessment to ensure the accuracy and completeness of the selected studies

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