Once Weekly Insulin Efsitora Alfa Shows Similar Efficacy to Daily Insulin

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Efsitora demonstrates noninferior reductions in hemoglobin A1c and similar rates of patients with an A1c of less than 7% compared with common daily insulin.

Investigational once weekly insulin efsitora alfa met the primary end point of noninferior A1c reduction compared to daily basal insulin for patients with type 2 diabetes. The results from QWINT-1 (NCT05662332), QWINT-3 (NCT05275400), and QWINT-4 (NCT05462756) were presented at the American Diabetes 85th Scientific Session 2025, with the results for QWINT-3 and QWINT-4 being posted in the New England Journal of Medicine.1,2

Diabetes, Insulin, Pharmacy, Medication, ADA

Efsitora demonstrates noninferior reductions in hemoglobin A1c and similar rates of patients with an A1c of less than 7% compared with common daily insulin. | Image Credit: Pixel-Shot - stock.adobe.com

"The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, which consisted of only 4 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," Julio Rosenstock, MD, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, said in a news release.1 "A simpler, once-weekly regimen with efsitora may help people with type 2 diabetes initiate and manage insulin therapy with the goal of improving blood sugar levels. Across all QWINT trials, the results showed that once-weekly efsitora controlled glucose as effectively as the most popular once-daily basal insulins."

In September 2024, the company announced results from the QWINT-2 and QWINT-5 trials, showing that once weekly insulin efsitora showed comparable results to daily insulin in reducing hemoglobin A1c levels for patients type 1 and type 2 diabetes. The investigational insulin met the primary end point of reducing hemoglobin A1c levels by 0.53% compared with 0.59% for insulin degludec once daily, resulting in hemoglobin A1c levels of 7.37% and 7.32%, respectively.3

For QWINT-1, efsitora demonstrated a reduction in A1c of 1.31% at week 52 compared 1.27% with glargine, according to the results. In QWINT-3 and QWINT-4, the reducing in A1c was 0.86% and 1.07% with efsitora compared with 0.75% with degludec and 1.07% with glargine, respectively, at week 26. For QWINT-3, the secondary end point of rate of clinically significant or severe nocturnal hypoglycemic events per patient-year of exposure up to week 78 was 0.11 for efsitora and 0.10 for degludec. For percent time in range 4 weeks prior to week 26, investigators reported 62.8% and 61.3%, respectively. Lastly, in QWINT-4, the secondary endpoint of patients achieving A1c of less than 7% at week 26 without nocturnal hypoglycemia was 39.5% with efsitora and 36.6% with glargine. For the rate of rate of clinically significant or severe nocturnal hypoglycemic events, investigators reported 0.67 and 1, respectively.1

"Building on Lilly's legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," Jeff Emmick, MD, PhD, senior vice president of product development at Lilly, said in the news release. "These results reinforce the potential for once weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach."

Furthermore, investigators reported overall safety profiles similar to the most commonly used daily basal insulins for type 2 diabetes.1

READ MORE: Insulin Management Resource Center

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REFERENCES
1. Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials. News release. Eli Lilly. June 22, 2025. Accessed July 7, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-once-weekly-insulin-efsitora-alfa-demonstrated-a1c
2. Rosenstock J, Bailey T, Connery L, et al. Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. N Engl J Med. Published online June 22, 2025. doi:10.1056/NEJMoa2502796
3. Massaro L. Lilly’s Once-Weekly Insulin Efsitora Offers Comparable Results to Daily Insulin in T1D, T2D. Drug Topics. September 12, 2024. Accessed July 7, 2025. https://www.drugtopics.com/view/lilly-s-once-weekly-insulin-efsitora-offers-comparable-results-to-daily-insulin-in-t1d-t2d
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