Current partner codePEPTIDESDE
NCT07228403·Phase 3·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 3

Enrollment

28

Locations

16

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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

Treatment arms and agents.

DRUG

Glepaglutide 10 mg

Administered twice weekly by subcutaneous injection for a maximum of 24 months

Timeline

From registration to results.

  1. First posted

    Nov 14, 2025

  2. Study start

    Dec 11, 2025

  3. Primary completion

    Sep 18, 2028

  4. Study completion

    Dec 31, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 30, 2026

Outcomes

What the study measures.

Primary outcomes

Number of treatment emergent adverse events (TEAEs)

Time frame · From baseline to the safety follow-up visit (A maximum of 25 months)

Secondary outcomes

Change in prescribed weekly parenteral support (PS) volume

Time frame · From baseline to Month 24 (End of Trial)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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.

Study locations

16 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.