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NCT03690206 · ClinicalTrials.gov registry record · Phase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
A Phase 3 study of Short Bowel Syndrome, sponsored by Zealand Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT03690206: Completed Phase 3 study of Short Bowel Syndrome, sponsored by Zealand Pharma.
NCT03690206 is a Phase 3 study of Short Bowel Syndrome that has completed, run by Zealand Pharma. The registered enrollment target is 106 participants, below the 179-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03690206, a Phase 3 study of Short Bowel Syndrome, has completed, sponsored by Zealand Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
Primary Outcome
Change in weekly PS volume from baseline to Week 24. Baseline actual weekly PS volume was defined as the actual PS volume derived from a valid 7-day period prior to visit 1 (Day 1), i.e. during the stabilization phase. The actual weekly PS volume at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 was derived as the actual weekly PS volume received during the valid 7-day period prior to the visit. The source for the derivation was the PS volumes recorded by the patients in the eDiary.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG glepaglutide
Study Locations (20)
Other
- UZ Leuven - Leuven
- The Royal Alexandra Hospital - Edmonton
- Western University - London
- University Health Network - Toronto General Hospital - Toronto
- Aalborg University Hospital - Aalborg
- Rigshospitalet - Copenhagen
- Hôpital Beaujon - Clichy
- Centre Hospitalier Lyon-Sud - Pierre-Bénite
- Charité - Universitätsmedizin Berlin - Berlin
- Universitätsklinikum Bonn - Bonn
- Universitätsklinikum Frankfurt - Med. Klinik I - Frankfurt
- Asklepios Kliniken Hamburg GmbH - Hamburg
- Universitätsmedizin Rostock - Rostock
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Illinois
- University of Chicago Children's Hospital - Chicago
Minnesota
- Mayo Clinic College of Medicine - Rochester
Nebraska
- University of Nebraska Medical Center - Omaha
New York
- Mount Sinai Hospital - New York
Ohio
- Cleveland Clinic - Cleveland
Tennessee
- Vanderbilt University Medical Center, Nashville - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2018-10-04 |
| Est. Completion | 2022-07-26 |
| Phase | Phase 3 |
What the finished NCT03690206 record still lists
NCT03690206 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Short Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03690206 names 20 study sites across 8 states, led by Other, District of Columbia, Illinois.
Frequently Asked Questions
What is clinical trial NCT03690206 about?
NCT03690206 is a clinical study titled "Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)". The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
What is the current status of trial NCT03690206?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2018-10-04. Estimated completion is 2022-07-26.
What conditions does trial NCT03690206 study?
This clinical trial studies the following conditions: Short Bowel Syndrome.
What interventions are being tested in trial NCT03690206?
The interventions under investigation include: Placebo (DRUG), glepaglutide (DRUG).
Who is sponsoring clinical trial NCT03690206?
This trial is sponsored by Zealand Pharma, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03690206 being conducted?
This trial has 20 study locations across District of Columbia, Illinois, Minnesota, Nebraska, New York. 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 NCT03690206's enrollment target sits among peer trials
106 7th of 17 higher than 11 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
-
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
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
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