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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Drug: glepaglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glepaglutide SC injections twice weekly<br>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<br>* Glucagon-Like Peptide-2 (GLP-2) analog<br>* Other names: ZP1848;|
| Experimental: Glepaglutide SC injections once weekly and placebo once weekly<br>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<br>* Glucagon-Like Peptide-2 (GLP-2) analog<br>* Other names: ZP1848;|

What is the study measuring?
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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 |