Efficacy and Safety Evaluation of Glepaglutide in Treatment of SBS

NCT ID: NCT07228403

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-11
• Study Completion Date: 2028-12-31

Brief 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.

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.

Conditions

Short Bowel Syndrome (SBS)

Keywords

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Short Bowel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-label Glepaglutide

Group Type: EXPERIMENTAL

Glepaglutide 10 mg

Intervention Type: DRUG

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

Interventions

Glepaglutide 10 mg

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

Intervention Type: DRUG

Other Intervention Names

ZP1848

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , 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

Countries

United States; Belgium; Canada; France; Germany; Poland; United Kingdom

Other Identifiers

2025-520775-81-00

Identifier Type: CTIS

Identifier Source: secondary_id

U1111-1317-8307

Identifier Type: OTHER

Identifier Source: secondary_id

ZP1848-25009

Identifier Type: -

Identifier Source: org_study_id