Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial (EASE SBS 3)

A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial

This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.

Study Overview

• Status: Enrolling by invitation
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Drug: Glepaglutide

• Study Type: Interventional
• Enrollment (Estimated): 129
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Universitair Ziekenhuis Leuven
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• France
  • Clichy, France
    • Hopital Beaujon
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon-Sud
• Germany
  • Berlin, Germany
    • Charité - Universitätsmedizin Berlin
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Frankfurt, Germany
    • Universitatsklinikum Frankfurt
  • Hamburg, Germany
    • Asklepios Kliniken Hamburg GmbH
  • Rostock, Germany
    • Universitätsmedizin Rostock
• Netherlands
  • Nijmegen, Netherlands
    • UMC Radboud Nijmegen
• Poland
  • Skawina, Poland
    • Szpital Skawina sp. z o.o. im. Stanley Dudricka
  • Łódź, Poland
    • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
• United Kingdom
  • Harrow, United Kingdom
    • St Mark's Hospital
  • London, United Kingdom
    • UCLH Foundation NHS Trust
  • Norwich, United Kingdom
    • Norfolk and Norwich University Hospitals
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic College of Medicin
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • 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 full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)

Exclusion Criteria:

• Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial
• Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients with remnant colon). Note. The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to End of Trial and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator
• Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of glepaglutide trial drug is allowed
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: once-weekly glepaglutide; All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)	Drug: Glepaglutide; Glepaglutide will be delivered in a single-use autoinjector.; Other Names: ZP1848

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and type of Adverse Events (AEs)	For AEs with onset or worsening following Visit 1	After 108 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and type of Serious Adverse Events (SAEs)	For AEs with onset or worsening following Visit 1	After 108 weeks
Incidence and type of Adverse Events of Special Interest (AESIs)	For AEs with onset or worsening following Visit 1	After 108 weeks
Change in body temperature		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in heart rate		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in blood pressure	Seated diastolic and systolic blood pressure	Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in body weight		Week 0 in lead-in trial (EASE SBS 1), Week 108
Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG)		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - hemoglobin		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - hematocrit		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - white blood cell count		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - platelet count		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - sodium		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - potassium		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - chloride		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - bicarbonate		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - blood urea nitrogen		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - creatinine		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - creatinine clearance		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - glucose		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - calcium		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - phosphorous		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - alkaline phosphatase		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - alanine aminotransferase (ALT)		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - aspartate aminotransferase (AST)		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - International Normalized Ratio (INR)		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - gamma-glutamyl transferase (GGT)		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - lactic dehydrogenase		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - conjugated bilirubin		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - total bilirubin		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - total protein		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - albumin		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - amylase		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - uric acid		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - C-reactive protein		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - blood		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - glucose		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - leukocytes		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - pH		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - osmolality		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - protein		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - sodium		Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - potassium		Week 0 in lead-in trial (EASE SBS 1), Week 108
Anti-glepaglutide antibodies		Week 0, Week 108
Antibody reactivity to ZP1848		Week 0, Week 108
Cross-reactivity to glucagon-like peptide-2 (GLP-2)		Week 0, Week 108
Glepaglutide neutralizing antibodies		Week 0, Week 108
Reduction in weekly Parenteral Support (PS) volume		Week 0 in lead-in trial (EASE SBS 1), Week 108
Reduction of at least 20 percent in weekly PS volume		Week 0 in lead-in trial (EASE SBS 1), Week 108
Reduction in days on PS greater than or equal to 1 day per week		Week 0 in lead-in trial (EASE SBS 1), Week 108
Reduction in weekly PS volume of 100 percent (weaned off)		Week 0 in lead-in trial (EASE SBS 1), Week 108

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome
• Other Study ID Numbers: ZP1848-20110; 2020-005502-25 (EudraCT Number); U1111-1261-3358 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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