Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

Short name EASE SBS 3

NCTNCT04881825Other idZP1848-20110Other id2020-005502-25Other idU1111-1261-3358

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 84 participants (actual)
Sponsor: Zealand Pharma · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 8 countries
United States, Belgium, Denmark, France, Germany, Netherlands, Poland, United Kingdom
Start: 16 Jun 2021
Primary completion: 30 Apr 2026
Completion: 30 Apr 2026
First posted: 11 May 2021
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

2021202220232024202520262027

Ph 3
EASE SBS 3
NCT04881825
16 Jun 2021 to 30 Apr 2026

Registry summary

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

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.

Interventions

GlepaglutideDrug

Arms1

Experimental
once-weekly glepaglutide
All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)

Primary outcomes1

Outcomes the sponsor listed as primary.

Incidence and type of Adverse Events (AEs)
Time frame · After 108 weeks
Registry description
For AEs with onset or worsening following Visit 1

Secondary outcomes(20)

Incidence and type of Serious Adverse Events (SAEs)
Time frame · After 108 weeks
Registry description
For AEs with onset or worsening following Visit 1
Incidence and type of Adverse Events of Special Interest (AESIs)
Time frame · After 108 weeks
Registry description
For AEs with onset or worsening following Visit 1
Change in body temperature
Time frame · 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
Change in blood pressure
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108
Registry description
Seated diastolic and systolic blood pressure
Change in body weight
Time frame · 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
Change in hematology - hemoglobin
Time frame · 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
Change in hematology - white blood cell count
Time frame · 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
Change in biochemistry - sodium
Time frame · 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
Change in biochemistry - chloride
Time frame · 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
Change in biochemistry - blood urea nitrogen
Time frame · 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
Change in biochemistry - creatinine clearance
Time frame · 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
Change in biochemistry - calcium
Time frame · Week 0 in lead-in trial (EASE SBS 1), Week 108

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 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

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