Eli Lilly and Company today shared detailed findings from its QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials, evaluating the safety and efficacy of its investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes. The studies involved participants who were either new to insulin, already on daily basal insulin, or using both daily basal and mealtime insulin. In each trial, once-weekly efsitora successfully achieved its primary endpoint, demonstrating non-inferior A1C reductions compared to standard daily basal insulin.
The full results were presented at the American Diabetes Association’s (ADA) 85th Scientific Sessions 2025. In parallel, data from QWINT-1 were published in The New England Journal of Medicine, while results from QWINT-3 and QWINT-4 appeared in The Lancet.
In QWINT-1, participants receiving efsitora saw an average A1C reduction of 1.31%, compared to a 1.27% reduction for those treated with insulin glargine at 52 weeks (efficacy estimand). Efsitora dosing in this trial followed a novel approach, utilizing just four fixed-dose titration steps at four-week intervals based on patients’ glucose control.
In QWINT-3, efsitora lowered A1C by 0.86% compared to 0.75% for insulin degludec at week 26, while in QWINT-4, both efsitora and insulin glargine produced identical A1C reductions of 1.07% at week 26 (efficacy estimand). In these two studies, dosing followed traditional insulin adjustment protocols tailored to individual glucose readings.
"The innovative fixed-dose regimen used in QWINT-1 offers the potential to simplify insulin initiation and management, addressing common barriers to starting insulin therapy in type 2 diabetes," said Dr. Julio Rosenstock, senior scientific advisor at Velocity Clinical Research, Medical City Dallas, clinical professor of medicine at University of Texas Southwestern Medical Center, and lead investigator for QWINT-1. "A once-weekly regimen like efsitora may help patients more easily begin and maintain insulin therapy while achieving meaningful improvements in glucose control. Across all QWINT studies, efsitora performed comparably to leading once-daily basal insulins."