DRUG
Glepaglutide
Glepaglutide will be delivered in a single-use autoinjector.
Status
Active, not recruiting
Phase
Phase 3
Enrollment
129
Locations
19
Results
Not posted
Publications
0
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.
Interventions
DRUG
Glepaglutide will be delivered in a single-use autoinjector.
Timeline
First posted
May 11, 2021
Study start
Jun 16, 2021
Primary completion
Apr 2026
Study completion
Apr 2026
Results posted
Not reported
Registry updated
Feb 2, 2026
Outcomes
Incidence and type of Adverse Events (AEs)
Time frame · After 108 weeks
For AEs with onset or worsening following Visit 1
Incidence and type of Serious Adverse Events (SAEs)
Time frame · After 108 weeks
For AEs with onset or worsening following Visit 1
Incidence and type of Adverse Events of Special Interest (AESIs)
Time frame · After 108 weeks
For AEs with onset or worsening following Visit 1
Change in body temperature
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in heart rate
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in blood pressure
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108
Seated diastolic and systolic blood pressure
Change in body weight
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108
Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG)
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - hemoglobin
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - hematocrit
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - white blood cell count
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108
Eligibility
Inclusion Criteria: * Informed consent obtained before any trial-related activity * Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127) Exclusion Criteria: * 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
Study locations
Belgium · Denmark · France · Germany · Netherlands · Poland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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