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The FDA has noted both the lack of human clinical trial data and uncertainty about long-term safety

The breadth of data was presented during a late-breaking symposium at the 2026 Scientific Sessions of the American Diabetes Association (ADA) in New Orleans, June 58, alongside the simultaneous publication of REIMAGINE 1 and 2 trial results in The Lancet Diabetes & Endocrinology and the REIMAGINE 3 trial results in The Lancet

11: Sikiric P, Seiwerth S, Skrtic A, Staresinic M, Strbe S, Vuksic A, Sikiric S, Bekic D, Penovic T, Drazenovic D, Becejac T, Tepes M, Madzar Z, Novosel L, Beketic Oreskovic L, Oreskovic I, Stupnisek M, Boban Blagaic A, Dobric I

After single IM administration at doses of 6, 30, or 150 g/kg, the T max values of each dose were 6.33, 8.67, and 8.17 min, respectively