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While this trial showed trends toward fat loss in the treatment groups, the primary endpoint of statistically significant weight reduction compared to placebo was not consistently achieved across all dose groups, and effect sizes were more modest than hoped

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The FDA label includes a boxed warning regarding thyroid C-cell tumors observed in rodent studies, contraindicating use in patients with personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2