While still an injectable, once-weekly dosing offers a simpler treatment regimen for patients.
Eli Lilly is looking to approach regulators for approval of its once-weekly insulin for type 2 diabetes after it proved non-inferior to daily dosing
Eli Lilly is looking to approach regulators for approval of its once-weekly insulin for type 2 diabetes (T2D) after it proved non-inferior to daily dosing.
The QWINT-1 (NCT05662332), QWINT-3 (NCT05275400), and QWINT-4 (NCT05462756) Phase III clinical trials evaluated efsitora alfa (efsitora) in T2D patients. They included those who had not used insulin before, had previously used daily insulin and those who used mealtime insulin.
While still an injectable formula, the once-weekly dosing would simplify treatment for patients.
In all three studies, a once-weekly dose of efsitora met the primary endpoint of non-inferior A1C reduction, with complete data presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025.
In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52. In QWINT-3, the therapy reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand while the treatment reduced A1C by 1.07% compared to 1.07% at the same time stamp in QWINT-4.
In QWINT-1, efsitora was titrated to four fixed doses at four-week intervals, as needed for blood glucose control. However, in QWINT-3 and QWINT-4, the drug was administered using traditional insulin dosing with adjustments based on glucose level.
Dr Julio Rosenstock, senior scientific adviser for Velocity Clinical Research at Medical City Dallas, and lead trial investigator for QWINT-1, said: “The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, which consisted of only four single-dose titration options, has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes.”
In all the studies, efsitora demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for T2D.
As a result of the studies, Lilly plans to submit for approval of efsitora by the end of this year.
After the market open today (23 June), Lilly’s stock rose 2.75%. The company has a market cap of $703.56bn.
This news comes as Lilly’s main weight loss and T2D competitor Novo Nordisk has cut ties with Hims and Hers over the distribution of the Danish company’s blockbuster Wegovy (semaglutide) weight loss drugs.
Novo Nordisk has been trying to cement itself as the leader in the T2D and weight loss space after Eli Lilly’s glucagon-like peptide 1 receptor agonist (GLP-1RA) was shown to be more effective than Novo Nordisk’s therapy.
Novo Nordisk is focusing its efforts on two pipeline candidates, namely CagriSema and amycretin, while also looking to establish partnerships with digital health companies to develop a platform for patients to access additional material. These include apps to scan a plate of food, as well as pharmacists to provide advice about GLP-1RA usage.
Novo Nordisk’s flagship semaglutide, marketed as Wegovy in weight loss and Ozempic in T2D, is forecast to make $49bn in sales in 2030.
Its main competitor, Eli Lilly’s tirzepatide, marketed as Zepbound in weight loss and Mounjaro in T2D, is projected to reach sales of $60.8bn.
