Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support

Summary

Part A:once weekly dosing for 4 weeks in patients with short bowel syndrome who require total parenteral nutrition; patients will complete period 1 and after a 6-10 week wash-out, they will enter period 2 (active treatment and placebo); Part B: treatment period 3, is an open label extension to part A and starts after a washout of 6-10 weeks after the last dose in treatment period 2. patients are dosed once weekly for 4 weeks.

Timeline

Start

2018-05-08

Primary completion

2019-11-21

Completion

2019-11-21

Publications

• Eliasson J, Hvistendahl MK, Freund N, Bolognani F, Meyer C, Jeppesen PB. Apraglutide, a novel glucagon-like peptide-2 analog, improves fluid absorption in patients with short bowel syndrome intestinal failure: Findings from a placebo-controlled, randomized phase 2 trial. JPEN J Parenter Enteral Nutr. 2022 May;46(4):896-904. doi: 10.1002/jpen.2223. Epub 2021 Sep 7.

Drugs

Indications