EASD 2024: Eli Lilly Unveils Phase III Data for Weekly Insulin in Diabetes

Eli Lilly, a renowned pharmaceutical company, has unveiled detailed outcomes from its Phase III QWINT-2 and QWINT-5 trials, highlighting that its once-weekly insulin efsitora (efsitora alfa) is as effective as daily insulin injections in reducing HbA1C levels for adults with type 2 and type 1 diabetes, respectively. The QWINT studies aim to establish that once-weekly efsitora is not inferior to daily insulin injections for managing diabetes. These findings were presented at the European Association for the Study of Diabetes (EASD) 2024 meeting in Spain and simultaneously published in prestigious journals, the New England Journal of Medicine and the Lancet.

The company is conducting five pivotal QWINT studies to demonstrate the efficacy of once-weekly efsitora compared to daily insulin injections. The recent data from QWINT-2 and QWINT-5 complement previously reported positive topline data from QWINT-1 and QWINT-3 trials. Both of these earlier studies achieved their primary endpoints, showing that efsitora's reduction in HbA1C levels was on par with that of insulin glargine and insulin degludec.

Diabetes treatments are a crucial segment for Eli Lilly, which has seen significant success in this area. The company's insulin products, including Humalog (insulin lispro), a fast-acting insulin, generated $1.67 billion in sales last year. Alongside its GLP-1 receptor agonists, which have been highly profitable for both diabetes and obesity indications, insulin treatments remain a key revenue driver for Lilly.

The QWINT-2 trial, a randomized open-label study (NCT05362058), involved 928 participants with type 2 diabetes. It compared the effectiveness of insulin efsitora to insulin degludec over a 52-week period. Participants using efsitora saw their mean HbA1C levels drop by −1.26 percentage points, similar to the −1.17 percentage point reduction observed in the insulin degludec group. Importantly, this non-inferiority in HbA1C reduction was consistent whether or not participants were also using GLP-1 receptor agonists.

A notable aspect of the QWINT-2 trial was the safety profile of efsitora. No episodes of severe hypoglycemia were reported in the efsitora group, whereas six participants in the degludec group experienced severe hypoglycemic episodes. The incidence of nocturnal hypoglycemic episodes was comparable between the two groups, with 32 occurrences in the efsitora group and 35 in the degludec group.

The QWINT-5 trial, also randomized and open-label (NCT05463744), enrolled 893 participants with type 1 diabetes. Participants received either insulin efsitora or insulin degludec, in combination with insulin lispro, over a 26-week period. The study found that those on efsitora reduced their mean HbA1C levels by -0.51%, which was close to the -0.56% reduction seen in the insulin degludec group.

However, the safety results from the QWINT-5 trial indicated a higher rate of hypoglycemia with efsitora. Specifically, 10% of patients in the efsitora group experienced severe hypoglycemia compared to 3% in the degludec group.

Eli Lilly continues to investigate once-weekly insulin efsitora through its ongoing QWINT studies to further substantiate its potential as an alternative to daily insulin injections for diabetes management. These findings could represent a significant advancement in diabetes treatment, offering patients a more convenient dosing regimen without compromising efficacy.

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