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

ID#: NCT03905707

Age: 18 - 90 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: May 07, 2019

End Date: November 05, 2022

Contact Information:
Medical Director
Senior Clinical Trial Manager
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.

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