Eli Lilly announces QWINT-2, QWINT-4 meet primary endpoints

Eli Lilly announced topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials evaluating once-weekly insulin efsitora alfa in adults with type 2 diabetes using insulin for the first time and those who require multiple daily insulin injections. In the treat-to-target clinical trials, efsitora showed non-inferior A1C reduction compared to the most commonly used daily basal insulins globally. QWINT-2 evaluated the efficacy and safety of once-weekly efsitora compared to once-daily insulin degludec for 52 weeks. The trial randomized insulin-naive adults with type 2 diabetes to receive efsitora once weekly or insulin degludec once daily and was also designed to assess efficacy in patients using and not using GLP-1 receptor agonists. The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 52. For the efficacy estimand, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95% respectively. In a key secondary endpoint, efsitora was non-inferior to insulin degludec in A1C change among participants using and not using GLP-1 receptor agonists. Further, participants taking efsitora spent 45 minutes more time in range4 and 37 minutes more in tight range5 without additional time in hypoglycemia in comparison to insulin degludec. QWINT-4 evaluated the efficacy and safety of efsitora compared to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized participants to receive efsitora once weekly or insulin glargine once daily, both of which were administered with insulin lispro. The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 26. For the efficacy estimand, both efsitora and insulin glargine reduced A1C by 1.07% resulting in an A1C of 7.12% and 7.11%, respectively6,7. In both QWINT-2 and QWINT-4, efsitora was safe and well-tolerated with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.58 with efsitora vs. 0.45 with insulin degludec and 6.6 with efsitora vs. 5.9 with insulin glargine. Detailed results from QWINT-2 will be presented at the European Association for the Study of Diabetes annual meeting 2024. Topline readouts from QWINT-1, QWINT-3 and QWINT-5 are anticipated later this year.