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No, it is not FDA-approved, and much of the evidence is preclinical

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This multi-receptor approach distinguishes it from existing licensed medicines such as semaglutide (Ozempic, Wegovy) or tirzepatide licensed in the UK as Mounjaro for type 2 diabetes and as Zepbound for obesity which act on fewer receptor pathways

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Its especially beneficial for individuals with absorption issues, such as those with gastrointestinal disorders or after certain surgeries