Lilly's once-weekly insulin equals daily regimens in key diabetes studies

Eli Lilly has announced that its innovative once-weekly insulin product, efsitora alfa (LY3209590), matches the efficacy of daily basal insulins in managing blood glucose levels for adults with type 2 diabetes. This revelation comes from the pivotal QWINT-2 and QWINT-4 clinical studies, with further results from three additional late-stage trials expected later in the year.

The findings place Lilly in direct competition with Novo Nordisk, which is also developing a similar long-acting insulin candidate. This rivalry extends beyond insulin treatments, as both companies are already contending in the market for GLP-1 drugs, specifically tirzepatide from Lilly and semaglutide from Novo Nordisk. These drugs are prescribed for both diabetes and weight loss, and both companies are struggling to meet the high market demand for obesity treatments.

“With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1c control, reduces the treatment burden of traditional daily injections, and potentially improves adherence for people with diabetes,” stated Jeff Emmick, Lilly's head of product development.

In the QWINT-2 study, 928 insulin-naïve adults with type 2 diabetes were randomized to receive either once-weekly efsitora or Novo Nordisk's Tresiba (insulin degludec) daily over 52 weeks. Meanwhile, QWINT-4 involved 730 adults who were already using basal insulin and receiving at least two daily injections of mealtime insulin. These participants were randomized to receive weekly efsitora or daily insulin glargine for 26 weeks, both combined with insulin lispro.

Both studies achieved their primary endpoints, demonstrating non-inferiority in reducing A1c levels compared to control groups. In QWINT-2, efsitora achieved a 1.34% reduction in A1c, resulting in a final level of 6.87%, while Tresiba reduced A1c by 1.26%, ending at 6.95%. Additionally, efsitora was shown to be non-inferior to Tresiba in reducing A1c among both users and non-users of GLP-1 agonists. Another key finding was that efsitora users spent 45 more minutes within the desired blood glucose range and 37 more minutes within a tight range without additional hypoglycemia episodes compared to those on Tresiba. Detailed results of QWINT-2 will be presented at the European Association for the Study of Diabetes (EASD) conference later this year.

In the QWINT-4 study, both efsitora and insulin glargine led to a 1.07% A1c reduction, with final levels of 7.12% and 7.11%, respectively.

Meanwhile, Novo Nordisk has submitted its once-weekly insulin icodec candidate to regulatory bodies in the US, Europe, and China based on data from its ONWARDS programme. A decision from the FDA was anticipated last month but has been delayed pending an advisory panel meeting scheduled for next week. In March, the European Medicines Agency’s advisory panel issued a positive opinion for icodec under the brand name Awiqli.

Lilly’s efsitora development program includes three additional studies: QWINT-1, QWINT-3, and QWINT-5. QWINT-1, expected to conclude in July, is evaluating efsitora against insulin glargine in adults with type 2 diabetes who are initiating basal insulin therapy. QWINT-3 compares efsitora with Tresiba in patients already on basal insulin, while QWINT-5 is testing efsitora against Tresiba in type 1 diabetes patients on multiple daily injections, with both studies slated to finish this month.