CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
Glepaglutidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04991311
NCT04991311Phase 3Completed

A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (SBS)

Zealand Pharma·interventional·Posted Aug 5, 2021·Updated Nov 22, 2024

In Brief

A Phase 3 clinical trial evaluating Glepaglutide for Short Bowel Syndrome. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedAug 5, 2021
Enrollment StartAug 10, 2021
Primary CompletionFeb 2, 2023
Study CompletionSep 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.9 years ago

Interventions

Glepaglutidedrug

Glepaglutide will be delivered in a single-use autoinjector.