Eli Lilly’s Insulin Efsitora Alfa Succeeds in Duo of Type 2 Diabetes Phase III Studies

Eli Lilly has shared positive study data from its QWINT clinical trial program evaluating once weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes. Across the QWINT-1 and QWINT-3 Phase III studies, efsitora demonstrated non-inferior A1C reduction compared to other popular daily basal insulins.¹

The QWINT-1 trial (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled study. It evaluated the efficacy and safety of efsitora compared to once daily insulin glargine for 52 weeks. The trial randomized 796 adults with type 2 diabetes who are insulin naïve to receive either efsitora once weekly in a single-use autoinjector or insulin glargine once daily.

Results from QWINT-1 showed efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine. With this mark, the trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 52.

The second Phase III study, QWINT-3 (NCT05275400), evaluated efsitora compared to once daily insulin degludec for 78 weeks in adults with type 2 diabetes currently treated with basal insulin. It was a multicenter, randomized, parallel-design, open-label trial. QWINT-3 randomized 986 participants 2:1 to receive either efsitora once weekly or insulin degludec once daily.

Like QWINT-1, QWINT-3 met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 26. Results showed efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec.

"Once weekly insulins, like efsitora, have the potential to transform diabetes care as we know it," Jeff Emmick, MD, PhD, senior vice president, product development, Lilly, said in a press release. "Many patients are reluctant to start insulin because of the burden it places on them. With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives."

Lilly plans to share more detailed results from both trials at an upcoming conference and have them published in a peer-reviewed journal.

Earlier in August, Lilly shared results from another Phase III study in the diabetes space of tirzepatide (Zepbound and Mounjaro) once weekly for long-term weight management. Topline data from the SURMOUNT-1 (NCT04184622) trial showed weekly tirzepatide injections significantly reduced the risk of progression to type 2 diabetes by 94% in adults with pre-diabetes and obesity or overweight compared to placebo. Additionally, sustained weight loss was observed during the treatment period.²

In a press release from the time, Emmick said, "Obesity is a chronic disease that puts nearly 900 million adults worldwide at an increased risk of other complications such as type 2 diabetes. Tirzepatide reduced the risk of developing type 2 diabetes by 94% and resulted in sustained weight loss over the three-year treatment period. These data reinforce the potential clinical benefits of long-term therapy for people living with obesity and pre-diabetes."

1. In a first-of-its-kind fixed dose study, once weekly insulin efsitora alfa leads to A1C reduction similar to daily insulin. News release. Eli Lilly. September 5, 2024. Accessed September 6, 2024. https://investor.lilly.com/news-releases/news-release-details/first-its-kind-fixed-dose-study-once-weekly-insulin-efsitora

2. Tirzepatide reduced the risk of developing type 2 diabetes by 94% in adults with pre-diabetes and obesity or overweight. News release. Eli Lilly. August 20, 2024. Accessed September 6, 2024. https://investor.lilly.com/news-releases/news-release-details/tirzepatide-reduced-risk-developing-type-2-diabetes-94-adults