Eli Lilly shares results from QWINT trials on once-weekly insulin efsitora for type 2 diabetes

 Eli Lilly and Company has announced detailed findings from its Phase 3 clinical trials—QWINT-1, QWINT-3, and QWINT-4—assessing the safety and efficacy of once-weekly investigational insulin efsitora alfa (efsitora) in adults with type 2 diabetes. The results were shared during the American Diabetes Association (ADA) 85th Scientific Sessions 2025. Simultaneously, data from QWINT-1 was published in The New England Journal of Medicine, while QWINT-3 and QWINT-4 findings were published in The Lancet.

The QWINT-1 trial evaluated adults initiating insulin therapy, QWINT-3 assessed those previously using daily basal insulin, and QWINT-4 included participants using both basal and mealtime insulin. In each study, efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin.

In QWINT-1, A1C levels were reduced by 1.31 per cent with efsitora versus 1.27 per cent with insulin glargine over 52 weeks. Efsitora was titrated through four fixed doses at four-week intervals. In QWINT-3, efsitora reduced A1C by 0.86 per cent compared to 0.75 per cent with insulin degludec over 26 weeks. QWINT-4 showed a 1.07 per cent reduction in A1C for both efsitora and insulin glargine at 26 weeks. In the latter two trials, insulin titration was based on patients’ glucose levels.

Dr Julio Rosenstock, senior scientific advisor for Velocity Clinical Research and lead investigator for QWINT-1, stated, “The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, which consisted of only four single-dose titration options, has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes. A simpler, once-weekly regimen with efsitora may help people with type 2 diabetes initiate and manage insulin therapy with the goal of improving blood sugar levels. Across all QWINT trials, the results showed that once-weekly efsitora controlled glucose as effectively as the most popular once-daily basal insulins.”

Jeff Emmick, MD, PhD, senior vice president of product development at Lilly, added, “Building on Lilly’s legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year. These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach. We look forward to working with regulatory agencies to bring this innovation to patients around the world.”

Across the three trials, efsitora showed a safety profile comparable to daily basal insulins. In QWINT-1, efsitora led to approximately 40 per cent fewer hypoglycaemic events compared to insulin glargine, with event rates of 0.50 versus 0.88 per patient-year at 52 weeks. In QWINT-3, the rates were 0.84 with efsitora and 0.74 with insulin degludec at 78 weeks. In QWINT-4, the corresponding figures were 6.6 and 5.9 at 26 weeks.

Lilly plans to submit efsitora for regulatory review for the treatment of adults with type 2 diabetes by the end of 2025.