Phase 3 Evaluation of Glepaglutide 10 mg Twice Weekly for Adults with Short Bowel Syndrome-Intestinal Failure Including Long-Term Safety Follow-Up

What this Trial Is About

This research evaluates the safety and effectiveness of glepaglutide 10 mg given twice weekly in adults with short bowel syndrome-intestinal failure SBS-IF. It is a phase 3, double-blind, randomized, placebo-controlled trial designed to confirm glepaglutides clinical effects and gather additional long-term safety information in this patient group. The study is sponsored by Zealand Pharma and involves multiple centers. Participants receive either glepaglutide or a placebo through subcutaneous injections twice a week. The trial includes an initial 24-week period to assess efficacy followed by a longer open-label phase to monitor long-term safety. The study compares changes in weekly parenteral support volume and clinical response rates between groups. During the trial, participants undergo regular assessments including monitoring of parenteral support needs, clinical response evaluations, and safety checks for adverse events. The primary outcome measures the change in weekly parenteral support volume from baseline to week 24. Secondary outcomes include response rates and safety data up to week 52. Overall participation can last several years, with ongoing safety follow-up until the study completion date in 2032.

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS