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Long-Lasting Insulin Takes Another Step Forward with Latest Clinical Trial Results

  • Eli Lilly disclosed the outcomes of the Phase 3 QWINT-1, QWINT-3, and QWINT-4 studies evaluating once-weekly insulin efsitora alfa for treating patients with type 2 diabetes requiring insulin therapy at the ADA 85th Scientific Sessions held on June 22, 2025, in Chicago.
  • These trials began in 2022 to evaluate efsitora's safety and efficacy, aiming to prove noninferiority in reducing HbA1c versus daily basal insulins, with no guarantee of future approval or consistent results.
  • Efsitora achieved HbA1c reductions from 8.20% to 7.05% at week 52, comparable to insulin glargine, and showed lower rates of clinically significant hypoglycemia while enabling a simpler fixed-dose weekly regimen.
  • Jeff Emmick said efsitora may eliminate over 300 injections annually, and Julio Rosenstock called the fixed-dose approach a potential paradigm shift, while 76% maintained fixed doses through the trial.
  • Eli Lilly aims to seek regulatory approval for efsitora by the end of 2025, offering a once-weekly insulin option that could make diabetes management easier for many; however, its widespread use will likely depend on factors such as pricing, insurance coverage, and accessibility.
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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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