Weekly Insulin Efsitora Alfa Matches Daily Insulin in A1C Reduction and Safety

Eli Lilly and Company has announced promising results from its QWINT-2 and QWINT-4 phase 3 clinical trials for the once-weekly insulin efsitora alfa (efsitora). These trials evaluated efsitora in adults with type 2 diabetes, both those new to insulin therapy and those requiring multiple daily injections. The results showed that efsitora achieved non-inferior A1C reduction compared to the widely used daily basal insulins, meeting the primary endpoint in both trials.

Jeff Emmick, MD, Ph.D., Senior Vice President of Product Development at Lilly, emphasized the significance of these findings for the diabetes community. He highlighted how efsitora, a once-weekly insulin, could provide equivalent blood sugar control to daily basal insulins while reducing the treatment burden and potentially improving adherence.

QWINT-2 focused on insulin-naïve adults with type 2 diabetes and evaluated the efficacy and safety of once-weekly efsitora compared to daily insulin degludec over 52 weeks. Participants were randomly assigned to receive either efsitora once weekly or insulin degludec once daily. The trial aimed to demonstrate non-inferiority in reducing A1C at week 52 and assess efficacy in patients using and not using GLP-1 receptor agonists. The trial succeeded in its primary endpoint, showing efsitora reduced A1C levels by 1.34% compared to 1.26% for insulin degludec, resulting in A1C levels of 6.87% and 6.95%, respectively. Additionally, participants on efsitora spent more time in target glucose ranges without additional hypoglycemia risk.

QWINT-4 evaluated efsitora's efficacy and safety compared to insulin glargine over 26 weeks in adults previously treated with basal insulin and requiring multiple daily mealtime insulin injections. Participants received either weekly efsitora or daily insulin glargine, both in combination with insulin lispro. This trial also met its primary endpoint, showing both treatments reduced A1C by 1.07%, resulting in A1C levels of 7.12% for efsitora and 7.11% for insulin glargine.

Both QWINT-2 and QWINT-4 demonstrated that efsitora was safe and well-tolerated. The rate of severe or clinically significant hypoglycemic events was similar between efsitora and the comparator insulins in both trials.

Detailed results from QWINT-2 will be shared at the European Association for the Study of Diabetes (EASD) Annual Meeting in 2024. Additional insights from the QWINT-1, QWINT-3, and QWINT-5 trials are expected later this year.

The QWINT phase 3 global clinical development program for efsitora began in 2022, enrolling over 4,000 individuals with type 1 or type 2 diabetes across five studies. QWINT-2 was a 52-week trial comparing efsitora to insulin degludec in insulin-naïve adults with type 2 diabetes. QWINT-4 was a 26-week trial comparing efsitora to insulin glargine in adults with type 2 diabetes who were already on basal insulin and multiple mealtime insulin injections.

Efsitora alfa is a novel once-weekly basal insulin designed for stable glucose levels. It combines a single-chain insulin variant with a human IgG2 Fc domain, allowing for consistent glucose control throughout the week. Currently in phase 3 development, efsitora aims to provide a new treatment option for adults with type 1 and 2 diabetes.

Eli Lilly and Company has a long history of pioneering medical discoveries, aiming to improve lives worldwide. Their efforts in diabetes care, obesity treatment, Alzheimer’s disease, immune system disorders, and cancer reflect their commitment to addressing significant health challenges. They prioritize innovative clinical trials and strive to ensure their medicines are accessible and affordable.

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