The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

Summary

The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. All participants in the trial will receive glepaglutide injections. Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.

Timeline

Start

2021-08-10

Primary completion

2023-02-02

Completion

2023-09-05

Outcome

Missed primary endpoint

registry p = 0.0585; Mean Difference (Final Values) 398.4 (95% CI -17.6 to 814.4) NCT04991311 ↗

Drugs

Indications