Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
NCT ID: NCT03690206
Last Updated: 2025-07-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2018-10-04
2022-07-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety Study of HPP593 in Subjects During and After Limb Immobilization
NCT01524406
SPACE Trial: Pyridostigmine vs Placebo in SMA Types 2, 3 and 4
NCT02941328
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
NCT03420781
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
NCT03426345
Clinical Trial of Sodium Phenylbutyrate in Children With Spinal Muscular Atrophy Type I
NCT00439218
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Glepaglutide SC injections twice weekly
Intervention: Glepaglutide
glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Glepaglutide SC injections once weekly and placebo once weekly
Intervention: Glepaglutide
glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Placebo
Placebo for glepaglutide
Placebo SC injections twice weekly
Intervention: Placebo
Placebo
Placebo for glepaglutide
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Placebo
Placebo for glepaglutide
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm and considered stable with regard to PS need. No restorative surgery planned in the trial period.
* Requiring PS at least 3 days per week and maintains a stable PS volume for at least 2 weeks.
* In case of remnant colon: documented colonoscopy which does not give rise to any safety concerns.
Exclusion Criteria
* Poorly controlled inflammatory bowel disease that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.
* Bowel obstruction.
* Known radiation enteritis or significant villous atrophy.
* Cardiac disease defined as: decompensated heart failure (New York Heart Association \[NYHA\] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening.
* Clinically significant abnormal ECG.
* Repeated systolic blood pressure measurements \> 180 mm Hg.
* Human immunodeficiency virus positive, acute liver disease, or unstable chronic liver disease.
* Any history of colon cancer. History of any other cancers unless disease-free state for at least 5 years.
* Estimated creatinine clearance \< 30 mL/min.
* Severe hepatic impairment.
* Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening.
* Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to Screening.
* Unstable systemic immunosuppressive therapy within 3 months prior to Screening.
* Unstable biological therapy within 6 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.
* Previous exposure to glepaglutide.
* Current, or within 30 days prior to Screening, participation in another interventional clinical trial that includes administration of an active compound.
* 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.
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zealand Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Zealand Pharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Aalborg University Hospital
Aalborg, , Denmark
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
UCLH Foundation NHS Trust
London, , United Kingdom
Salford Royal NHS Foundation Trust
Manchester, , United Kingdom
University of East Anglia
Norwich, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jeppesen PB, Vanuytsel T, Subramanian S, Joly F, Wanten G, Lamprecht G, Kunecki M, Rahman F, Nielsen TSS, Berner-Hansen M, Pape UF, Mercer DF. Glepaglutide, a Long-Acting Glucagon-like Peptide-2 Analogue, Reduces Parenteral Support in Patients With Short Bowel Syndrome: A Phase 3 Randomized Controlled Trial. Gastroenterology. 2025 Apr;168(4):701-713.e6. doi: 10.1053/j.gastro.2024.11.023. Epub 2024 Dec 19.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZP1848-17111
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.