Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Short Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT03905707

Run by

Zealand Pharma

People needed

145

Starts

2019-05-07

Expected to finish

2026-04-01

Last updated by the study team

2026-01-30

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 lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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