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

NCT07228403 | Enrolling By Invitation Phase 3 FDA Drug

• 3 other identifiers: ZP1848-250092025-520775-81-00U1111-1317-8307
• Study Type: interventional
• Target: 35
• Locations: 7 countries
• Sites: 16

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

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

Secondary Outcomes (1)

• Change in prescribed weekly parenteral support (PS) volume

  From baseline to Month 24 (End of Trial)

Study Arms (1)

Open-label Glepaglutide

EXPERIMENTAL

Drug: Glepaglutide 10 mg

Interventions

Glepaglutide 10 mg DRUG

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

Also known as: ZP1848

Open-label Glepaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (16)

Mayo Clinic - PPDS

Rochester, Minnesota, 55905-0001, United States

Location

Lied Transplant Center at Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Cleveland Clinic-9500 Euclid Ave

Cleveland, Ohio, 44195-0001, United States

Location

Vanderbilt University Medical Center-Tennesse-1211 21st Ave S

Nashville, Tennessee, 37212-2700, United States

Location

UZ Leuven - PPDS

Leuven, 3000, Belgium

Location

LHSC - University Hospital

London, Ontario, N6A 4V2, Canada

Location

AP-HP - Hôpital Beaujon

Clichy, Hauts-de-Seine, 92118, France

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Szpital Skawina sp. z o.o. im. Stanley Dudricka

Skawina, Lesser Poland Voivodeship, 32-050, Poland

Location

Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego CMKP

Warsaw, Masovian Voivodeship, 00-416, Poland

Location

Wojewódzki Szpital Specjalistycznyo im. M. Pirogowa w Lodzi

Lodz, 90-531, Poland

Location

St Mark's Hospital (Central Middlesex Hospital)

Ealing, NW10 7NS, United Kingdom

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): September 18, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); GB (1); CA (1); BE (1); FR (1); DE (5); US (4)