Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
NCT ID: NCT03905707
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
145 participants
INTERVENTIONAL
2019-05-07
2026-04-30
Brief Summary
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Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Glepaglutide SC injections twice weekly
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly.
In this long term safety study, there is no placebo arm.
glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Glepaglutide SC injections once weekly and placebo once weekly
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly.
In this long term safety study, there is no placebo arm.
glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Interventions
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glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Zealand Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Zealand Pharma
Role: STUDY_DIRECTOR
Zealand Pharma
Locations
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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
UCLH Foundation NHS Trust
London, , United Kingdom
University of East Anglia
Norwich, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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Other Identifiers
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ZP1848-17127
Identifier Type: -
Identifier Source: org_study_id
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