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Trial · Interventional

Active, not recruitingPhase 3Registry data

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

Short name EASE SBS 6

NCTNCT07228403 (opens ClinicalTrials.gov in a new tab)Other idZP1848-25009Other id2025-520775-81-00Other idU1111-1317-8307Other id2025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
28 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
7 countries

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

Start
11 Dec 2025
Primary completion
18 Sept 2028 (estimated)
Completion
31 Dec 2028 (estimated)
First posted
14 Nov 2025
Last update posted
30 Jul 2026
Conditions
Short Bowel Syndrome (SBS)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 3

    EASE SBS 6

    NCT07228403

    11 Dec 2025 to est. 31 Dec 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Glepaglutide 10 mgDrug

Arms1

  • Experimental

    Open-label Glepaglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of treatment emergent adverse events (TEAEs)

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

Secondary outcomes(1)

  1. Change in prescribed weekly parenteral support (PS) volume

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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