Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
- Registration Number
- NCT03905707
- Lead Sponsor
- Zealand Pharma
- Brief Summary
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
A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 145
- Informed consent obtained before any trial-related activity
- Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glepaglutide SC injections twice weekly glepaglutide Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly. In this long term safety study, there is no placebo arm. Glepaglutide SC injections once weekly and placebo once weekly glepaglutide 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.
- Primary Outcome Measures
Name Time Method Safety - Adverse Events 2 years Incidence and type of Adverse Events
- Secondary Outcome Measures
Name Time Method Safety - Changes in blood pressure from baseline 2 years Changes in systolic and diastolic blood pressure will be reported
Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG) 2 years Number of patients with clinically significant changes in ECG will be reported
Energy content (amino acids) 2 years Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline
Safety - Serious Adverse Events 2 years Incidence and type of Serious Adverse Events
Immunogenicity - Occurrence of anti-drug antibodies 2 years Occurrence of antibodies against glepaglutide
Number of patients with 40 percent change in PS volume per week 2 years Achieving 40 percent in PS volume from baseline
Change in weekly Parenteral Support (PS) volume 2 years Change in weekly PS volume from baseline
Days off PS 2 years Achieving 1 or more days per week off PS
Weaned off PS 2 years Reduction in weekly PS volume of 100 percent (weaned off)
Energy content (lipids) 2 years Change in lipids content (in kcal/L or kjoule/L) of PS from baseline
Days on PS 2 years Change in number of days on PS per week from baseline
Safety - Adverse Events of Special Interest 2 years Incidence and type of Adverse Events of Special Interest
Number of patients with 20 percent reduction in PS volume 2 years Achieving at least 20 percent reduction in weekly PS volume from baseline
Energy content (glucose) 2 years Change in glucose content (in kcal/L or kjoule/L) of PS from baseline
Changes in fluid composite effect 2 years Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline
Trial Locations
- Locations (27)
University of Chicago Children's Hospital
🇺🇸Chicago, Illinois, United States
St Mark's Hospital
🇬🇧Harrow, United Kingdom
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Mayo Clinic College of Medicine
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Vanderbilt University Medical Center, Nashville
🇺🇸Nashville, Tennessee, United States
UZ Leuven
🇧🇪Leuven, Belgium
The Royal Alexandra Hospital
🇨🇦Edmonton, Canada
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