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Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials

  • On June 22, 2025, Eli Lilly revealed that its investigational once-weekly insulin, efsitora alfa, demonstrated A1C reductions comparable to those achieved with daily basal insulin treatments in individuals with type 2 diabetes at the ADA's 85th Scientific Sessions in Chicago.
  • The announcement followed the 2022 start of the QWINT Phase 3 program, which included three global trials assessing efsitora in different patient populations to demonstrate safety and efficacy compared to daily basal insulins.
  • Across QWINT-1, QWINT-3, and QWINT-4, efsitora reduced A1C similarly or slightly more than insulin glargine or degludec while exhibiting comparable or reduced rates of significant hypoglycemia, with a notable 40% fewer hypoglycemic events in QWINT-1 versus glargine.
  • Jeff Emmick, Lilly's SVP of product development, stated that efsitora may advance treatment by eliminating over 300 injections annually, and Dr. Julio Rosenstock highlighted the regimen's potential to simplify insulin therapy through fixed-dose titration.
  • Efsitora is expected to be filed with regulatory authorities by Lilly by the end of 2025, with the goal of enhancing insulin adherence and streamlining glucose management, while recognizing the inherent uncertainties related to future clinical trial outcomes and the approval process.
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Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials

Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing

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Medscape broke the news in United States on Sunday, June 22, 2025.
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