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Trial · Interventional

RecruitingPhase 3Registry data

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Short name EASE SBS 5

NCTNCT07197944 (opens ClinicalTrials.gov in a new tab)Other idZP1848-23029Other id2024-512486-14-00Other idU1111-1302-6092
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
90 participants (estimated)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Quadruple masking
Countries
14 countries

United States, Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden

Start
11 Feb 2026
Primary completion
23 Oct 2028 (estimated)
Completion
28 Feb 2032 (estimated)
First posted
30 Sept 2025
Last update posted
29 Sept 2026
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202820302032
  1. Ph 3

    EASE SBS 5

    NCT07197944

    11 Feb 2026 to est. 28 Feb 2032

Registry summary

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

The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data. Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.

Interventions

  • GlepaglutideDrug
  • PlaceboOther

Arms2

  • Experimental

    Glepaglutide Group

  • Placebo comparator

    Placebo Group

    Placebo for glepaglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in weekly Parenteral Support (PS) volume

    Time frame · Baseline to Week 24

Secondary outcomes(10)

  1. Proportion of participants achieving clinical response

    Time frame · Baseline to Week 52

    Registry description

    Defined as achieving a reduction of at least 20% in weekly PS volume

  2. Proportion of participants achieving clinical response

    Time frame · Baseline to Week 20 and Week 24

    Registry description

    Defined as achieving a reduction of at least 20% in weekly PS volume

  3. Proportion of participants with a reduction in days on PS ≥1 day/week

    Time frame · Baseline to Week 52

  4. Proportion of participants with a reduction in days on PS ≥1 day/week

    Time frame · Baseline to Week 24

  5. Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)

    Time frame · Baseline to Week 52

  6. Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)

    Time frame · Baseline to Week 24

  7. Proportion of participants achieving 'much better' Patient Global Impression of Change (PGIC) status

    Time frame · Week 24

    Registry description

    PGIC scoring categories are: 'Much better', 'A little better', 'No change', 'A little worse', and 'Much worse'

  8. Change in weekly PS volume

    Time frame · Baseline to Week 12

  9. Change in weekly PS volume

    Time frame · Baseline to Week 8

  10. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame · Baseline to Week 52

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 up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Key Inclusion Criteria: * Signed informed consent; * Age of 18 to 90 years; * A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening); * Stable PS need of ≥3 days per week; * No restorative surgery planned during the trial period; * Having a stoma or colon in continuity. Key Exclusion Criteria: * More than 2 SBS- or PS-related hospitalizations within 6 months before screening; * Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial; * History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction; * BMI \<18.5 kg/m\^2.

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