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Active, not recruiting Phase 3

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

NCT07228403 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-12-11
Last updated
2026-07-30

Condition(s) studied

Short Bowel Syndrome (SBS)

Investigational drug(s) / intervention(s)

Glepaglutide 10 mg →

Glepaglutide 10 mg: Administered twice weekly by subcutaneous injection for a maximum of 24 months

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Has provided signed informed consent and agrees to comply with protocol requirements. * Is being 1. Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or 2. Actively treated in the EASE SBS 3 trial. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Number of treatment emergent adverse events (TEAEs) — From baseline to the safety follow-up visit (A maximum of 25 months)

Trial sites (16)

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

More Zealand Pharma trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07228403 on ClinicalTrials.gov ↗ ← All trials in France