NCT03905707

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

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	glepaglutide	Glucagon-Like Peptide-2 (GLP-2) analog

Timeline

• Start date: 2019-05-07
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2019-04-05
• Last updated: 2026-01-30

Locations

27 sites across 9 countries: United States, Belgium, Canada, Denmark, France, Germany, Netherlands, Poland, United Kingdom

Regulatory

• FDA-regulated drug study