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

• Status: Recruiting
• Trial end date: 2022-11-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand Pharma
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

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