drugset / Trial / NCT07228403

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

NCT07228403 ↗

Phase 3 Enrolling by invitation 35 enrolled Zealand Pharma
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-12-11
Primary completion
2028-09-18
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Glepaglutide Peptide 10 mg Subcutaneous

Indications