Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
Purpose
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.
Condition
- Short Bowel Syndrome
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Glepaglutide SC injections twice weekly |
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly. In this long term safety study, there is no placebo arm. |
|
|
Experimental Glepaglutide SC injections once weekly and placebo once weekly |
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. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Zealand Pharma
Study Contact
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)