A Phase 3, Double-blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice Weekly, Followed by a Long-term, Open-label Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure (SBS-IF)
Zealand Pharma
Summary
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data. Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.
Description
The trial is a phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial to confirm the efficacy and safety of glepaglutide 10 mg twice weekly, followed by a long-term, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Signed informed consent; * Age of 18 to 90 years; * A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening); * Stable PS need of ≥3 days per week; * No restorative surgery planned during the trial period; * Having a stoma or colon in continuity. Key Exclusion Criteria: * More than 2 SBS- or PS-related hospitalizations within 6 months before screening; * Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely…
Interventions
- DrugGlepaglutide
Subcutaneous (SC) injections twice weekly
- OtherPlacebo
SC injections twice weekly
Locations (23)
- Washington University Center for Advanced MedicineSt Louis, Missouri
- Lied Transplant Center at Nebraska Medical CenterOmaha, Nebraska
- New York Presbyterian Hospital-Columbia University Medical CenterNew York, New York
- Vanderbilt University Medical CenterNashville, Tennessee
- Universitätsklinikum AKH WienVienna, State of Vienna
- Rigshospitalet-Blegdamsvej 9Copenhagen