Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
Running, not enrolling · Phase 3
Conditions studied: Short Bowel Syndrome
In brief
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.
Key facts
- Study ID
- NCT04881825
- Run by
- Zealand Pharma
- People needed
- 129
- Starts
- 2021-06-16
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2026-02-02
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Informed consent obtained before any trial-related activity
- Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)
You may not qualify if…
- Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial
- Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients with remnant colon). Note. The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to End of Trial and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator
- Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of glepaglutide trial drug is allowed
- Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods
Where it is running
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Mayo Clinic College of Medicin — Rochester, Minnesota, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Vanderbilt University Medical Center, Nashville — Nashville, Tennessee, United States
- Universitair Ziekenhuis Leuven — Leuven, Belgium
- Rigshospitalet — Copenhagen, Denmark
- Hôpital Beaujon — Clichy, France
- Centre Hospitalier Lyon-Sud — Pierre-Bénite, France
- Charité - Universitätsmedizin Berlin — Berlin, Germany
- Universitätsklinikum Bonn — Bonn, Germany
- Universitätsklinikum Frankfurt — Frankfurt, Germany
- Asklepios Kliniken Hamburg GmbH — Hamburg, Germany
- Universitätsmedizin Rostock — Rostock, Germany
- UMC Radboud Nijmegen — Nijmegen, Netherlands
- Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi — Lodz, Poland
- Szpital Skawina sp. z o.o. im. Stanley Dudricka — Skawina, Poland
- St Mark's Hospital — Harrow, United Kingdom
- UCLH Foundation NHS Trust — London, United Kingdom
- Norfolk and Norwich University Hospitals — Norwich, United Kingdom
Full record on ClinicalTrials.gov
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