Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome

Running, not enrolling · Phase 3

Conditions studied: Short Bowel Syndrome (SBS)

In brief

The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.

Key facts

Study ID

NCT07228403

Run by

Zealand Pharma

People needed

28

Starts

2025-12-11

Expected to finish

2028-12-31

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has provided signed informed consent and agrees to comply with protocol requirements.
• Is being
• Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or
• Actively treated in the EASE SBS 3 trial.

You may not qualify if…

• Has a condition, disease, or circumstance that, in the opinion of the investigator, would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial.
• Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed.
• Had major protocol deviation(s) (as determined by the sponsor) in the EASE SBS 2 or EASE SBS 3 trial that would affect the conduct of the present trial.
• Has permanently discontinued the trial treatment because of an AE, assessed as related to the trial drug in the EASE SBS 2 or EASE SBS 3 trial. (Note: AEs are treatment-emergent unless otherwise specified.)
• If female, is of childbearing potential, pregnant, breastfeeding, intends to become pregnant, or is not using contraceptive methods. Refer to Section 10.2.2 for the definition of contraception.
• Has a known or suspected hypersensitivity to glepaglutide or related products.
• Has committed to an institution by virtue of an order issued by the judicial or administrative authorities.
• Is an employee of the sponsor or investigator or otherwise dependent on them.

Where it is running

• Mayo Clinic - PPDS — Rochester, Minnesota, United States
• Lied Transplant Center at Nebraska Medical Center — Omaha, Nebraska, United States
• Cleveland Clinic-9500 Euclid Ave — Cleveland, Ohio, United States
• Vanderbilt University Medical Center-Tennesse-1211 21st Ave S — Nashville, Tennessee, United States
• UZ Leuven - PPDS — Leuven, Belgium
• LHSC - University Hospital — London, Ontario, Canada
• AP-HP - Hôpital Beaujon — Clichy, Hauts-de-Seine, France
• Universitätsklinikum Frankfurt — Frankfurt am Main, Hesse, Germany
• Universitätsmedizin Rostock — Rostock, Mecklenburg-Vorpommern, Germany
• Universitätsklinikum Bonn — Bonn, North Rhine-Westphalia, Germany
• Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany
• Asklepios Klinik St. Georg — Hamburg, Germany
• Szpital Skawina sp. z o.o. im. Stanley Dudricka — Skawina, Lesser Poland Voivodeship, Poland
• Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego CMKP — Warsaw, Masovian Voivodeship, Poland
• Wojewódzki Szpital Specjalistycznyo im. M. Pirogowa w Lodzi — Lodz, Poland
• St Mark's Hospital (Central Middlesex Hospital) — Ealing, United Kingdom

Full record on ClinicalTrials.gov

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