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NCT Number: NCT03905707

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZ Leuven, Leuven, Belgium

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About this study

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glepaglutide

Drug

Glucagon-Like Peptide-2 (GLP-2) analog

Other names: ZP1848

Primary outcomes

  1. Safety - Adverse Events

    Time frame: 2 years

    Incidence and type of Adverse Events

Secondary outcomes

  1. Safety - Serious Adverse Events

    Time frame: 2 years

    Incidence and type of Serious Adverse Events

  2. Safety - Adverse Events of Special Interest

    Time frame: 2 years

    Incidence and type of Adverse Events of Special Interest

  3. Safety - Changes in blood pressure from baseline

    Time frame: 2 years

    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

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

  5. Immunogenicity - Occurrence of anti-drug antibodies

    Time frame: 2 years

    Occurrence of antibodies against glepaglutide

  6. Change in weekly Parenteral Support (PS) volume

    Time frame: 2 years

    Change in weekly PS volume from baseline

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

    Time frame: 2 years

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

  8. Days off PS

    Time frame: 2 years

    Achieving 1 or more days per week off PS

  9. Weaned off PS

    Time frame: 2 years

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

  10. Changes in fluid composite effect

    Time frame: 2 years

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

  11. Energy content (lipids)

    Time frame: 2 years

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

  12. Energy content (glucose)

    Time frame: 2 years

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

  13. Energy content (amino acids)

    Time frame: 2 years

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

  14. Days on PS

    Time frame: 2 years

    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

    Achieving 40 percent in PS volume from baseline

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study title

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

Acronym: EASE SBS 2

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2019
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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