Eli Lilly and Company has revealed positive topline results from the Phase III clinical trials of once-weekly insulin efsitora alfa (efsitora) to treat adults with type 2 diabetes (T2D).
The QWINT-1 and QWINT-3 trials compared efsitora to insulin glargine and insulin degludec, respectively.
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The 52-week QWINT-1 study met its primary endpoint by demonstrating that efsitora’s A1C reduction was non-inferior to that of insulin glargine.
In the 78-week QWINT-3 trial, efsitora met its primary endpoint, showing a similar A1C reduction to insulin degludec at week 26.
The company noted that these results suggest that efsitora could be an effective once-weekly basal insulin therapy for T2D.
Participants in the trials experienced approximately two additional hours in the target glucose range per day, indicating improved glucose control with efsitora treatment.
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By GlobalDataThe safety and tolerability profile of efsitora was in line with those of the daily basal insulin therapies.
A fusion protein, efsitora alfa combines a single-chain variant of insulin with a human IgG2 Fc domain, designed for once-weekly subcutaneous administration.
Its low peak-to-trough ratio may contribute to more stable glucose levels throughout the week.
Eli Lilly product development senior vice-president Jeff Emmick said: “Once weekly insulins like efsitora have the potential to transform diabetes care as we know it.
“Many patients are reluctant to start insulin because of the burden it places on them. With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives.”
In August, the company reported that its blockbuster drug Zepbound (tirzepatide) demonstrated to be effective in preventing the development of T2D in patients who are overweight or obese in a Phase III study.
