Eli Lilly Reveals Promising Results from QWINT-2 and QWINT-4 Phase III Trials for Efsitora Alfa, a Weekly Insulin Treatment for Adults with Type 2 Diabetes

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Eli Lilly announced promising results from the QWINT-2 and QWINT-4 Phase III trials for their once-weekly insulin, efsitora alfa, in adults with type 2 diabetes. According to the company, the trials showed that efsitora is non-inferior in A1C reduction compared to daily basal insulins, offering a potentially improved patient adherence and reduced treatment burden. Reportedly, efsitora offers equivalent blood sugar control to daily basal insulins with dosing only once a week.

QWINT-2 found that efsitora displayed an A1C reduction of 1.34% compared to insulin degludec and that its participants spent more time in target glucose ranges without additional hypoglycemia. For QWINT-4, efsitora was compared to insulin glargine. Both efsitora and glargine reduced A1C by 1.07%, and efsitora was reported to be well-tolerated, demonstrating a safety profile similar to daily insulin.¹

"The results of QWINT-2 and QWINT-4 are a significant milestone for the diabetes community and demonstrate that efsitora as a weekly insulin provides blood sugar control equivalent to daily basal insulins," said Jeff Emmick, MD, PhD, SVP, product development, Lilly, in a press release. "With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes."

Lilly isn’t the only company working on weekly doses of insulin for the treatment of diabetes. In June 2022, Novo Nordisk revealed that it had achieved positive results from its ONWARDS 1 and ONWARDS 6 Phase IIIa clinical trials with once-weekly insulin icodec. According to the company, the studies achieved the primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared to insulin glargine for ONWARDS 1, additionally achieving the primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin icodec compared to insulin degludec. Both trials demonstrated a generally safe profile.²

“The results of the main phase of ONWARDS 1 confirm the strong results seen in ONWARDS 2 and strengthen the profile of once-weekly insulin icodec which has the potential to become the ideal insulin for people with type 2 diabetes initiating insulin treatment”, said Martin Holst Lange, EVP, Development, Novo Nordisk, in a press release. “The results of the main phase of ONWARDS 6 reflect the complexity of introducing a once-weekly insulin in basal bolus treatment for people with type 1 diabetes. Novo Nordisk remains confident that once-weekly insulin icodec holds the potential to become a safe and efficacious treatment in type 1 diabetes.”

Results from the QWINT-2 will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024, while results from QWINT-4 and other QWINT studies are expected at a later point this year.¹

References

1. With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin. Lilly. May 16, 2024. Accessed May 20, 2024. https://investor.lilly.com/news-releases/news-release-details/once-week-dosing-insulin-efsitora-alfa-delivers-a1c-reduction

2. Novo Nordisk achieves primary objectives of ONWARDS 1 and 6 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin glargine U100 in ONWARDS 1. Novo Nordisk. June 3, 2022. Accessed May 20, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=118349