INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY) announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin.
In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand. In the trial, efsitora was titrated to four fixed doses at four-week intervals, as needed for blood glucose control. In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand. In QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine at week 26 for the efficacy estimand. In these two trials, efsitora was administered using traditional insulin dosing with adjustments based on each patient's glucose level.
Across the three trials, efsitora demonstrated an overall safety profile comparable to two of the most commonly used daily basal insulin therapies for type 2 diabetes. In QWINT-1, efsitora was associated with approximately 40% fewer hypoglycemic events than insulin glargine, with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure at 0.50 for efsitora versus 0.88 for insulin glargine at 52 weeks. In QWINT-3, the respective rates were 0.84 for efsitora and 0.74 for insulin degludec at 78 weeks. In QWINT-4, the rates were 6.6 for efsitora and 5.9 for insulin glargine at 26 weeks.
Lilly said it plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year.
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