802-P: Steady-State Pharmacokinetics and Glucodynamics of Once-Weekly Insulin Efsitora Alfa (Efsitora) in Individuals with Type 2 Diabetes (T2D)

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Introduction and Objective: Efsitora is a novel basal insulin designed for once-weekly administration. Methods: This multiple-dose, euglycemic clamp study assessed steady-state pharmacokinetics (PK) and glucodynamics of efsitora in 56 adults with T2D without prior insulin treatment (mean [±SD] age, 61.9 ± 5.98 years; HbA1c, 7.1 ± 0.64%; BMI, 31.7 ± 3.20 kg/m2). After a lead-in period with once-daily degludec for dose-finding, eligible participants received a one-time starting dose of 12 U/kg efsitora and weekly doses of 4 U/kg for 9 weeks. After the last dose of efsitora, 24-hour clamps were conducted on Days 1, 4, and 7. Results: Clinical steady-state (90% of trough steady-state) was achieved for efsitora between the 3rd and 5th weekly dose using a one-time starting dose. At steady-state, the model-predicted glucose infusion rate profile over the weekly dosing interval demonstrated a stable glucose-lowering effect of efsitora (Figure 1). The maximum glucose infusion rate occurred on Day 4 with low day-to-day variability. Efsitora was safe and well tolerated, as observed in prior studies. Conclusion: Efsitora demonstrated a flat and prolonged PK profile providing a constant level of insulin and as a result a stable glucose lowering response across the weekly dosing interval. Disclosure J. Leohr: Employee; Eli Lilly and Company. O. Klein: None. T. Heise: Research Support; ADOCIA, Afon Technology, AstraZeneca, Altimmune Inc, Biocon, BIOTON, Civica Foundation, Eli Lilly and Company, Zealand Pharma A/S, Betagenon, Cass Pharmaceuticals, Novo Nordisk A/S, Corteria, Zealand Pharma A/S, Cytoki, Enyo Pharma, Gan & Lee Pharmaceuticals, Genova, Nanexa, Neodyne, SamChunDang Pharma. Co., Spiden, Sun Pharmaceutical Industries Ltd. Speaker's Bureau; Eli Lilly and Company, Novo Nordisk A/S. Consultant; Gan & Lee Pharmaceuticals. J.M. Bue-Valleskey: Employee; Eli Lilly and Company. S. Suriyapperuma: Employee; Eli Lilly and Company. M.G. Case: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. D.G. Waters: Employee; Eli Lilly and Company. E.J. Pratt: Employee; Eli Lilly and Company. E. Zijlstra: None. H. Linnebjerg: None.

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