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Urgent cases may qualify for expedited review within 72 hours if providers submit supporting documentation demonstrating symptom severity

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Early-stage investigational compound

Limited data exist regarding tirzepatide's effects on other inflammatory markers such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-) in humans, with most evidence coming from preclinical studies

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The only Phase I trial (NCT02465229) was withdrawn in 2016 before enrollment