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Trial · Interventional

CompletedPhase 3Registry data

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

Short name EASE SBS 2

NCTNCT03905707 (opens ClinicalTrials.gov in a new tab)Other idZP1848-17127
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
150 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Quadruple masking
Countries
9 countries

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

Start
7 May 2019
Primary completion
30 Apr 2026
Completion
30 Apr 2026
First posted
5 Apr 2019
Last update posted
8 Sept 2026
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202220242026
  1. Ph 3

    EASE SBS 2

    NCT03905707

    7 May 2019 to 30 Apr 2026

Registry summary

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

The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Interventions

  • glepaglutideDrug

Arms2

  • Experimental

    Glepaglutide SC injections twice weekly

    Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly. In this long term safety study, there is no placebo arm.

  • Experimental

    Glepaglutide SC injections once weekly and placebo once weekly

    Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly. In this long term safety study, there is no placebo arm.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Safety - Adverse Events

    Time frame · 2 years

    Registry description

    Incidence and type of Adverse Events

Secondary outcomes(15)

  1. Safety - Serious Adverse Events

    Time frame · 2 years

    Registry description

    Incidence and type of Serious Adverse Events

  2. Safety - Adverse Events of Special Interest

    Time frame · 2 years

    Registry description

    Incidence and type of Adverse Events of Special Interest

  3. Safety - Changes in blood pressure from baseline

    Time frame · 2 years

    Registry description

    Changes in systolic and diastolic blood pressure will be reported

  4. Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)

    Time frame · 2 years

    Registry description

    Number of patients with clinically significant changes in ECG will be reported

  5. Immunogenicity - Occurrence of anti-drug antibodies

    Time frame · 2 years

    Registry description

    Occurrence of antibodies against glepaglutide

  6. Change in weekly Parenteral Support (PS) volume

    Time frame · 2 years

    Registry description

    Change in weekly PS volume from baseline

  7. Number of patients with 20 percent reduction in PS volume

    Time frame · 2 years

    Registry description

    Achieving at least 20 percent reduction in weekly PS volume from baseline

  8. Days off PS

    Time frame · 2 years

    Registry description

    Achieving 1 or more days per week off PS

  9. Weaned off PS

    Time frame · 2 years

    Registry description

    Reduction in weekly PS volume of 100 percent (weaned off)

  10. Changes in fluid composite effect

    Time frame · 2 years

    Registry description

    Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline

  11. Energy content (lipids)

    Time frame · 2 years

    Registry description

    Change in lipids content (in kcal/L or kjoule/L) of PS from baseline

  12. Energy content (glucose)

    Time frame · 2 years

    Registry description

    Change in glucose content (in kcal/L or kjoule/L) of PS from baseline

  13. Energy content (amino acids)

    Time frame · 2 years

    Registry description

    Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline

  14. Days on PS

    Time frame · 2 years

    Registry description

    Change in number of days on PS per week from baseline

  15. Number of patients with 40 percent change in PS volume per week

    Time frame · 2 years

    Registry description

    Achieving 40 percent in PS volume from baseline

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.

Completed trials do not always post results.

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
Inclusion Criteria: * Informed consent obtained before any trial-related activity * Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073) Exclusion Criteria: * Withdrawal of consent from the lead-in trial * Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results * Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening * Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods

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