Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment.

ABSTRACT:

Background

Glepaglutide is a novel, ready-to-use, long-acting, glucagon-like peptide-2 (GLP-2) analog intended for the treatment of patients with short bowel syndrome (SBS). This study investigated the impact of renal function on the pharmacokinetics and safety of glepaglutide.

Methods

In this 3-site, non-randomized, open-label study, 16 subjects were enrolled: 4 with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m²), 4 with end stage renal disease (ESRD) not on dialysis (eGFR < 15 mL/min/1.73 m²), and 8 matching controls with normal renal function (eGFR ≥ 90 mL/min/1.73 m²). Blood samples were collected over a 14-day period following a single subcutaneous (SC) dose of glepaglutide 10 mg. Safety and tolerability were assessed throughou

SUBMITTER: Agersnap MA 

PROVIDER: S-EPMC10085944 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature