DRUG
glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
Status
Active, not recruiting
Phase
Phase 3
Enrollment
145
Locations
27
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
Full detailed description
A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 5, 2019
Study start
May 7, 2019
Primary completion
Apr 2026
Study completion
Apr 2026
Results posted
Not reported
Registry updated
Jan 30, 2026
Outcomes
What the study measures.
Primary outcomes
Safety - Adverse Events
Time frame · 2 years
Incidence and type of Adverse Events
Secondary outcomes
Safety - Serious Adverse Events
Time frame · 2 years
Incidence and type of Serious Adverse Events
Safety - Adverse Events of Special Interest
Time frame · 2 years
Incidence and type of Adverse Events of Special Interest
Safety - Changes in blood pressure from baseline
Time frame · 2 years
Changes in systolic and diastolic blood pressure will be reported
Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)
Time frame · 2 years
Number of patients with clinically significant changes in ECG will be reported
Immunogenicity - Occurrence of anti-drug antibodies
Time frame · 2 years
Occurrence of antibodies against glepaglutide
Change in weekly Parenteral Support (PS) volume
Time frame · 2 years
Change in weekly PS volume from baseline
Number of patients with 20 percent reduction in PS volume
Time frame · 2 years
Achieving at least 20 percent reduction in weekly PS volume from baseline
Days off PS
Time frame · 2 years
Achieving 1 or more days per week off PS
Weaned off PS
Time frame · 2 years
Reduction in weekly PS volume of 100 percent (weaned off)
Changes in fluid composite effect
Time frame · 2 years
Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 90 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Informed consent obtained before any trial-related activity * Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073) Exclusion Criteria: * Withdrawal of consent from the lead-in trial * Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results * Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening * Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods
Study locations
27 registered sites.
Belgium · Canada · 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
University of Chicago Children's Hospital
Chicago, Illinois, United States
Mayo Clinic College of Medicine
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai Hospital
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Vanderbilt University Medical Center, Nashville
Nashville, Tennessee, United States
UZ Leuven
Leuven, Belgium
The Royal Alexandra Hospital
Edmonton, Canada
Western University
London, Canada
University Health Network - Toronto General Hospital
Toronto, Canada
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 - Med. Klinik I
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
Solumed
Poznan, Poland
Szpital Skawina sp. z o.o. im. Stanley Dudricka
Skawina, Poland
St Mark's Hospital
Harrow, United Kingdom
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Glepaglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome
Zealand Pharma · Short Bowel Syndrome (SBS)
Phase 3
Active, not recruiting
28
2026-07
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Zealand Pharma · Short Bowel Syndrome
Phase 3
Recruiting
90
2026-04
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
Zealand Pharma · Short Bowel Syndrome
Phase 3
Active, not recruiting
129
2026-02
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
Zealand Pharma · Short Bowel Syndrome
Phase 3
Completed
106
2025-07
The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
Zealand Pharma · Short Bowel Syndrome
Phase 3
Completed
12
2024-11
A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.
Zealand Pharma · Healthy
Phase 1
Completed
85
2021-07
Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function
Zealand Pharma · Renal Impairment
Phase 1
Completed
16
2020-11
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
Zealand Pharma · Healthy Subjects
Phase 1
Completed
75
2017-12
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.