Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS (EASE SBS 2)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Drug: glepaglutide

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 145
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Leuven
• Canada
  • Edmonton, Canada
    • The Royal Alexandra Hospital
  • London, Canada, N6A 4V2
    • Western University
  • Toronto, Canada
    • University Health Network - Toronto General Hospital
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• France
  • Clichy, France
    • Hôpital Beaujon
  • Pierre-Bénite, France
    • Centre hospitalier Lyon-Sud
• Germany
  • Berlin, Germany
    • Charité - Universitätsmedizin Berlin
  • Bonn, Germany, 53127
    • Universitatsklinikum Bonn
  • Frankfurt, Germany
    • Universitätsklinikum Frankfurt - Med. Klinik I
  • Hamburg, Germany
    • Asklepios Kliniken Hamburg GmbH
  • Rostock, Germany
    • Universitätsmedizin Rostock
• Netherlands
  • Nijmegen, Netherlands
    • UMC Radboud Nijmegen
• Poland
  • Lodz, Poland
    • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
  • Poznan, Poland
    • SOLUMED
  • Skawina, Poland
    • Szpital Skawina sp. z o.o. im. Stanley Dudricka
• United Kingdom
  • Harrow, United Kingdom
    • St Mark's Hospital
  • London, United Kingdom
    • UCLH Foundation NHS Trust
  • Norwich, United Kingdom
    • University of East Anglia
  • Southampton, United Kingdom
    • University Hospital Southampton NHS Foundation Trust
• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Children's Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic College of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198-3285
      • University of Nebraska Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Tennessee
    • Nashville, Tennessee, United States, 68198-3285
      • Vanderbilt University Medical Center, Nashville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: glepaglutide; Glucagon-Like Peptide-2 (GLP-2) analog; Other Names: ZP1848
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.	Drug: glepaglutide; Glucagon-Like Peptide-2 (GLP-2) analog; Other Names: ZP1848

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Adverse Events	Incidence and type of Adverse Events	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Serious Adverse Events	Incidence and type of Serious Adverse Events	2 years
Safety - Adverse Events of Special Interest	Incidence and type of Adverse Events of Special Interest	2 years
Safety - Changes in blood pressure from baseline	Changes in systolic and diastolic blood pressure will be reported	2 years
Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)	Number of patients with clinically significant changes in ECG will be reported	2 years
Immunogenicity - Occurrence of anti-drug antibodies	Occurrence of antibodies against glepaglutide	2 years
Change in weekly Parenteral Support (PS) volume	Change in weekly PS volume from baseline	2 years
Number of patients with 20 percent reduction in PS volume	Achieving at least 20 percent reduction in weekly PS volume from baseline	2 years
Days off PS	Achieving 1 or more days per week off PS	2 years
Weaned off PS	Reduction in weekly PS volume of 100 percent (weaned off)	2 years
Changes in fluid composite effect	Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline	2 years
Energy content (lipids)	Change in lipids content (in kcal/L or kjoule/L) of PS from baseline	2 years
Energy content (glucose)	Change in glucose content (in kcal/L or kjoule/L) of PS from baseline	2 years
Energy content (amino acids)	Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline	2 years
Days on PS	Change in number of days on PS per week from baseline	2 years
Number of patients with 40 percent change in PS volume per week	Achieving 40 percent in PS volume from baseline	2 years

Collaborators and Investigators

• Sponsor: Zealand Pharma
• Investigators: Study Director: Zealand Pharma, Zealand Pharma

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Pathological Conditions, Signs and Symptoms; Short Bowel Syndrome
• Other Study ID Numbers: ZP1848-17127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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