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

Core Insights - Eli Lilly's investigational once-weekly insulin efsitora alfa has shown promising results in Phase 3 clinical trials, indicating its potential to simplify insulin management for adults with type 2 diabetes [1][8] - The company plans to submit efsitora for regulatory approval by the end of 2025, aiming to enhance treatment options for diabetes patients [8] Study Results - In the QWINT-1 study, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52, demonstrating non-inferiority [2][4] - QWINT-3 showed efsitora reducing A1C by 0.86% compared to 0.75% for insulin degludec at week 26 [2][5] - In QWINT-4, efsitora achieved an A1C reduction of 1.07%, equal to that of insulin glargine at week 26 [2][7] Safety Profile - Efsitora demonstrated a safety profile comparable to daily basal insulins, with approximately 40% fewer hypoglycemic events compared to insulin glargine in QWINT-1 [5][6] - The rates of severe or clinically significant hypoglycemic events per patient-year were 0.50 for efsitora versus 0.88 for insulin glargine at 52 weeks [6][7] Treatment Regimen - The fixed-dose regimen in QWINT-1 consisted of four single-dose titration options, which may facilitate insulin therapy initiation for type 2 diabetes patients [3][10] - Efsitora's once-weekly administration could potentially eliminate over 300 injections per year, reducing the burden of insulin therapy [6][10] Clinical Development - The QWINT Phase 3 clinical program began in 2022, enrolling over 3,000 participants across four global studies [9][10] - The trials included diverse populations from multiple countries, enhancing the robustness of the findings [11][12]