A Phase 1, Open-Label, Single-Dose Study to Evaluate Pharmacokinetics of MEDI0382 in Patients with Renal Impairment

MEDI0382, an oxyntomodulin-like peptide with targeted GLP-1 and glucagon receptor activity, is in development for T2DM. This open-label, parallel-group study (NCT03235375) evaluated PK of SC MEDI0382 (100 µg; single dose) in subjects (N = 37) grouped by renal function: Group 1, ESRD or severe renal impairment (RI; CrCl < 20 mL/min); Group 2, severe RI (CrCl ≥ 20 mL/min to < 30 mL/min); Group 3, healthy controls (CrCl ≥ 90 mL/min); Group 4a, moderate RI (CrCl ≥ 30 mL/min to < 45 mL/min); and Group 4b, moderate RI (CrCl ≥ 45 mL/min to < 60 mL/min). Coprimary endpoints were geometric mean ratio AUC48h and Cmax of MEDI0382 (Table 1). MEDI0382 had similar PK profiles across all groups (Table 2). This suggests that PK of MEDI0382 is unaffected by renal function, allowing dosing in subjects with RI in future trials. Disclosure G.K. Klein: None. M. Petrone: Employee; Self; MedImmune. Y. Yang: Employee; Self; MedImmune. T. Hoang: Employee; Self; MedImmune. S. DiCostanza: Employee; Self; AstraZeneca. L. Hansen: Employee; Self; AstraZeneca, MedImmune. Stock/Shareholder; Self; Bristol-Myers Squibb Company, Novo Nordisk A/S. A. Flor: Employee; Self; AstraZeneca.