Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)

Completed · Phase 3 · Has a placebo group

Conditions studied: Short Bowel Syndrome

In brief

The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Key facts

Study ID

NCT03690206

Run by

Zealand Pharma

People needed

106

Starts

2018-10-04

Expected to finish

2022-07-26

Last updated by the study team

2025-07-17

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.
• 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.

You may not qualify if…

• More than 2 SBS-related or PS-related hospitalizations within 6 months prior to Screening. No SBS-related hospitalizations within 30 days prior to randomization.
• 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.

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
• 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

Full record on ClinicalTrials.gov

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