1720-P: Effect of Renal Impairment on the Pharmacokinetics and Safety of Bofanglutide

Introduction and Objective: Bofanglutide is a bi-weekly GLP-1 analog being developed for the treatment of type 2 diabetes and overweight or obesity. This trial evaluated the pharmacokinetic (PK) and safety profile of bofanglutide in participants with varying degrees of renal impairment compared with those with normal renal function. Methods: Participants were enrolled and classified into four groups based on eGFR: normal renal function, mild, moderate, and severe renal impairment (n=8 per group). Each participant received a single subcutaneous dose of 3 mg bofanglutide. Plasma concentrations were measured up to 840 h post-dose. Primary endpoints included maximum plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-last) and infinity (AUC0-inf). Results: Bofanglutide exposure was comparable across renal impairment groups and the normal renal function group. The geometric least-squares mean ratios for Cmax, AUC0-last, and AUC0-inf were all close to 1, with the upper bounds of the 90% confidence intervals slightly exceeding the predefined 1.25 equivalence limit (up to 1.28) in five comparisons. No serious adverse events related to bofanglutide were reported, and most adverse events were gastrointestinal-related. Conclusion: There were no clinically relevant effects of renal impairment on bofanglutide PK. Dose adjustment is not required for participants with renal impairment. Disclosure W. Zhao: None. H. Shen: None. J. Pan: None. L. Shao: None. J. Zhao: None. M. Ding: None. T. Xie: None. Y. Li: None. J. Wang: None. X. Yang: None. H. Wu: None. W. Chen: None.