NCT07228403

Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome

A 104-week, Multicenter, Open-label, Single-arm, Phase 3 Extension Trial Investigating the Long-term Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Rolling Over From the EASE SBS 2 or 3 Trials

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.

Detailed description

This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.

Conditions

• Short Bowel Syndrome (SBS)

Interventions

Type	Name	Description
DRUG	Glepaglutide 10 mg	Administered twice weekly by subcutaneous injection for a maximum of 24 months

Timeline

• Start date: 2025-12-11
• Primary completion: 2028-09-18
• Completion: 2028-12-31
• First posted: 2025-11-14
• Last updated: 2026-02-02

Locations

16 sites across 7 countries: United States, Belgium, Canada, France, Germany, Poland, United Kingdom

Regulatory

• FDA-regulated drug study