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NCT04881825 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
A Phase 3 study of Short Bowel Syndrome, sponsored by Zealand Pharma.
- Active
- Registry status
- Phase 3
- Development phase
- 129
- Enrollment target
- 19
- Study locations
NCT04881825: Active Phase 3 study of Short Bowel Syndrome, sponsored by Zealand Pharma.
NCT04881825 is a Phase 3 study of Short Bowel Syndrome that is active but no longer recruiting, run by Zealand Pharma. The registered enrollment target is 129 participants, below the 177-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (27% lower). The trial reports 19 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04881825, a Phase 3 study of Short Bowel Syndrome, is active but no longer recruiting, sponsored by Zealand Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 129 participants
- Enrollment target
- 19
- Study locations
Study Summary
This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.
Primary Outcome
For AEs with onset or worsening following Visit 1
Conditions Studied
Interventions
- DRUG Glepaglutide
Study Locations (19)
Other
- Universitair Ziekenhuis Leuven - Leuven
- Rigshospitalet - Copenhagen
- Hôpital Beaujon - Clichy
- Centre Hospitalier Lyon-Sud - Pierre-Bénite
- Charité - Universitätsmedizin Berlin - Berlin
- Universitätsklinikum Bonn - Bonn
- Universitätsklinikum Frankfurt - Frankfurt
- Asklepios Kliniken Hamburg GmbH - Hamburg
- Universitätsmedizin Rostock - Rostock
- UMC Radboud Nijmegen - Nijmegen
- Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi - Lodz
- Szpital Skawina sp. z o.o. im. Stanley Dudricka - Skawina
- St Mark's Hospital - Harrow
- UCLH Foundation NHS Trust - London
- Norfolk and Norwich University Hospitals - Norwich
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Minnesota
- Mayo Clinic College of Medicin - Rochester
Nebraska
- University of Nebraska Medical Center - Omaha
Tennessee
- Vanderbilt University Medical Center, Nashville - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2021-06-16 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
What the registry record for NCT04881825 still lists
NCT04881825 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 177-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Short Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Glepaglutide is the first listed.
NCT04881825 lists 19 locations in 5 states (Other, District of Columbia, Minnesota).
Frequently Asked Questions
What is clinical trial NCT04881825 about?
NCT04881825 is a clinical study titled "Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial". This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekl...
What is the current status of trial NCT04881825?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2021-06-16. Estimated completion is 2026-04.
What conditions does trial NCT04881825 study?
This clinical trial studies the following conditions: Short Bowel Syndrome.
What interventions are being tested in trial NCT04881825?
The interventions under investigation include: Glepaglutide (DRUG).
Who is sponsoring clinical trial NCT04881825?
This trial is sponsored by Zealand Pharma, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04881825 being conducted?
This trial has 19 study locations across District of Columbia, Minnesota, Nebraska, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Short Bowel Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04881825's enrollment target sits among peer trials
129 6th of 17 higher than 12 of 17 other Short Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Short Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
RECRUITING · Phase 3
-
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
ACTIVE NOT RECRUITING · Phase 3
-
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
ACTIVE NOT RECRUITING · Phase 3
-
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
COMPLETED · Phase 3
-
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
COMPLETED · Phase 3
-
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
COMPLETED · Phase 3
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