DRUG
Glepaglutide 10 mg
Administered twice weekly by subcutaneous injection for a maximum of 24 months
Status
Active, not recruiting
Phase
Phase 3
Enrollment
28
Locations
16
Results
Not posted
Publications
0
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.
This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.
Interventions
DRUG
Administered twice weekly by subcutaneous injection for a maximum of 24 months
Timeline
First posted
Nov 14, 2025
Study start
Dec 11, 2025
Primary completion
Sep 18, 2028
Study completion
Dec 31, 2028
Results posted
Not reported
Registry updated
Jul 30, 2026
Outcomes
Number of treatment emergent adverse events (TEAEs)
Time frame · From baseline to the safety follow-up visit (A maximum of 25 months)
Change in prescribed weekly parenteral support (PS) volume
Time frame · From baseline to Month 24 (End of Trial)
Eligibility
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.
Study locations
Belgium · Canada · France · Germany · Poland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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