Weekly insulin efsitora alfa matches daily insulin in A1C reduction in novel study

Eli Lilly and Company recently unveiled encouraging results from their Phase 3 clinical trials, QWINT-1 and QWINT-3, examining the efficacy of once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes. These trials focused on insulin-naïve individuals and those transitioning from daily basal insulin injections. Efsitora was demonstrated to be non-inferior in reducing A1C levels compared to the most commonly used daily basal insulins worldwide.

Jeff Emmick, M.D., Ph.D., the senior vice president of product development at Lilly, emphasized the transformative potential of efsitora in diabetes management. He noted that many patients are hesitant to begin insulin therapy due to its complexity. A simplified, once-weekly regimen like efsitora could ease the initiation and management of insulin therapy, minimizing its impact on daily life.

QWINT-1 was a 52-week trial comparing the efficacy and safety of once-weekly efsitora with daily insulin glargine in insulin-naïve adults. Participants were randomized to receive either efsitora through a single-use autoinjector or daily insulin glargine. The study achieved its primary endpoint, showing non-inferior A1C reduction for efsitora compared to insulin glargine. Specifically, efsitora reduced A1C by 1.31% to an A1C level of 6.92%, while insulin glargine reduced it by 1.27% to an A1C of 6.96%. Additionally, efsitora demonstrated a 40% lower rate of severe or clinically significant hypoglycemic events compared to insulin glargine.

QWINT-3 was a 78-week trial evaluating efsitora against daily insulin degludec in adults already being treated with basal insulin. Participants in this study also showed non-inferior A1C reduction with efsitora over 26 weeks. Efsitora reduced A1C by 0.86% to an A1C level of 6.93%, compared to a 0.75% reduction to an A1C of 7.03% for insulin degludec. Participants using efsitora or insulin degludec also spent more time within the target glucose range of 70-180 mg/dL, with efsitora users achieving 62.8% of time in range compared to 61.3% for insulin degludec. 

Both trials reported that the safety and tolerability of efsitora were comparable to those of daily basal insulin therapies. The comprehensive data from these studies will be presented at future medical congresses and published in peer-reviewed journals.

The QWINT clinical trial program began in 2022 and includes over 4,000 participants with type 1 or type 2 diabetes across five global studies. QWINT-1 involved 796 participants from the U.S., Argentina, Mexico, and Puerto Rico. The primary goal was to demonstrate non-inferiority in reducing A1C levels over 52 weeks with efsitora compared to insulin glargine. QWINT-3, which included 986 participants from multiple countries, aimed to show non-inferiority in reducing A1C levels with efsitora compared to insulin degludec over 26 weeks.

Efsitora is designed for once-weekly subcutaneous administration, combining a single-chain variant of insulin with a human IgG2 Fc domain. It aims to provide more stable glucose levels throughout the week due to its low peak-to-trough ratio. Currently, efsitora is in phase 3 development for adults with type 1 and type 2 diabetes.

Lilly, a company dedicated to improving global health through innovative medicines, has been at the forefront of life-changing discoveries for nearly 150 years. Their portfolio includes treatments for diabetes, obesity, Alzheimer's disease, immune system disorders, and difficult-to-treat cancers. Lilly is committed to making its medicines accessible and affordable while reflecting global diversity in its clinical trials.

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