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Eli Lilly's weekly insulin efsitora shows positive results in Phase 3
US-based pharmaceutical company Eli Lilly on Monday announced findings from the Phase 3 clinical trials for its once-weekly investigational insulin drug, efsitora alfa (efsitora), indicating positive safety and efficacy results for A1C reduction compared to daily basal insulin.
While basal insulin is a long-acting insulin administered once or twice a day, efsitora is designed for once-weekly subcutaneous injection. The company also shared detailed results from the Phase 3 QWINT-1, QWINT-3 and QWINT-4 trials.
The QWINT-1 trial evaluated adults initiating insulin therapy, while QWINT-3 assessed individuals previously using daily basal insulin. 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,' the company stated.
According to Lilly, in QWINT-1, efsitora reduced A1C by 1.31 per cent compared to 1.27 per cent for insulin glargine at week 52 for the efficacy estimand. In QWINT-3, the drug reduced A1C by 0.86 per cent compared to 0.75 per cent for insulin degludec at week 26.
'In QWINT-4, efsitora reduced A1C by 1.07 per cent, matching insulin glargine's reduction of 1.07 per cent at week 26 for the efficacy estimand,' Lilly added.
The Phase 3 global clinical development programme for the diabetes drug began in 2022 and included over 3,000 participants with type 2 diabetes across four global registration studies.
Commenting on the results, Jeff Emmick, senior vice president of product development at Lilly, said that the once-weekly insulin therapy may offer a significant advancement for people with type 2 diabetes who need insulin, by eliminating over 300 injections a year.
The company added that the drug also has the potential to provide more stable glucose levels—reducing glucose variability—throughout the week.
Eli Lilly now plans to submit the drug to global regulatory agencies for the treatment of type 2 diabetes in adults by the end of 2026.
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