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

January 29, 2026 updated by: Zealand Pharma

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • Universitair Ziekenhuis Leuven
  • 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
        • Universitätsklinikum Bonn
      • Frankfurt, Germany
        • Universitätsklinikum Frankfurt
      • 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
      • 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
        • Norfolk and Norwich University Hospitals
  • United States
    • District of Columbia
      • Washington D.C., 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and type of Adverse Events (AEs)
Time Frame: After 108 weeks
For AEs with onset or worsening following Visit 1
After 108 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and type of Serious Adverse Events (SAEs)
Time Frame: After 108 weeks
For AEs with onset or worsening following Visit 1
After 108 weeks
Incidence and type of Adverse Events of Special Interest (AESIs)
Time Frame: After 108 weeks
For AEs with onset or worsening following Visit 1
After 108 weeks
Change in body temperature
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in heart rate
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in blood pressure
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Seated diastolic and systolic blood pressure
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in body weight
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG)
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - hemoglobin
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - hematocrit
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - white blood cell count
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in hematology - platelet count
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - sodium
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - potassium
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - chloride
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - bicarbonate
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - blood urea nitrogen
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - creatinine
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - creatinine clearance
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - glucose
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - calcium
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - phosphorous
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - alkaline phosphatase
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - alanine aminotransferase (ALT)
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - aspartate aminotransferase (AST)
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - International Normalized Ratio (INR)
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - gamma-glutamyl transferase (GGT)
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - lactic dehydrogenase
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - conjugated bilirubin
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - total bilirubin
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - total protein
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - albumin
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - amylase
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - uric acid
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in biochemistry - C-reactive protein
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - blood
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - glucose
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - leukocytes
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - pH
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - osmolality
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - protein
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - sodium
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Change in urinalysis - potassium
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Anti-glepaglutide antibodies
Time Frame: Week 0, Week 108
Week 0, Week 108
Antibody reactivity to ZP1848
Time Frame: Week 0, Week 108
Week 0, Week 108
Cross-reactivity to glucagon-like peptide-2 (GLP-2)
Time Frame: Week 0, Week 108
Week 0, Week 108
Glepaglutide neutralizing antibodies
Time Frame: Week 0, Week 108
Week 0, Week 108
Reduction in weekly Parenteral Support (PS) volume
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Reduction of at least 20 percent in weekly PS volume
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
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
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108
Reduction in weekly PS volume of 100 percent (weaned off)
Time Frame: Week 0 in lead-in trial (EASE SBS 1), Week 108
Week 0 in lead-in trial (EASE SBS 1), Week 108

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Zealand Pharma, Zealand Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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