Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (EASE SBS 6)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Short Bowel Syndrome (SBS)
• Intervention / Treatment: Drug: Glepaglutide 10 mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven - PPDS
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • LHSC - University Hospital
• France
  • Hauts-de-Seine
    • Clichy, Hauts-de-Seine, France, 92118
      • AP-HP - Hôpital Beaujon
• Germany
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitätsklinikum Frankfurt
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18057
      • Universitätsmedizin Rostock
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Universitatsklinikum Bonn
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10117
      • Charité - Universitätsmedizin Berlin
• Poland
  • Lodz, Poland, 90-531
    • Wojewódzki Szpital Specjalistycznyo im. M. Pirogowa w Lodzi
  • Lesser Poland Voivodeship
    • Skawina, Lesser Poland Voivodeship, Poland, 32-050
      • Szpital Skawina sp. z o.o. im. Stanley Dudricka
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 00-416
      • Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego CMKP
• United Kingdom
  • Ealing, United Kingdom, NW10 7NS
    • St Mark's Hospital (Central Middlesex Hospital)
• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - PPDS
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Lied Transplant Center at Nebraska Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195-0001
      • Cleveland Clinic-9500 Euclid Ave
  • Tennessee
    • Nashville, Tennessee, United States, 37212-2700
      • Vanderbilt University Medical Center-Tennesse-1211 21st Ave S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label Glepaglutide	Drug: Glepaglutide 10 mg; Administered twice weekly by subcutaneous injection for a maximum of 24 months; Other Names: ZP1848

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of treatment emergent adverse events (TEAEs)	From baseline to the safety follow-up visit (A maximum of 25 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in prescribed weekly parenteral support (PS) volume	From baseline to Month 24 (End of Trial)

Collaborators and Investigators

• Sponsor: Zealand Pharma

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): September 18, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 14, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pathologic Processes; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Postoperative Complications; Short Bowel Syndrome; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutritional and Metabolic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Postoperative Complications; Short Bowel Syndrome; Malabsorption Syndromes; Pathological Conditions, Signs and Symptoms
• Other Study ID Numbers: ZP1848-25009; 2025-520775-81-00 (Ctis); U1111-1317-8307 (Other Identifier: UT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No