A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Glepaglutide 10 mg Twice Weekly with Long-term Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure

What this Trial Is About

Researchers are evaluating glepaglutide, given twice weekly, in adults with short bowel syndrome-intestinal failure (SBS-IF) to confirm its effectiveness and safety. This Phase 3, double-blind, randomized, placebo-controlled trial also aims to collect long-term safety data. The study is sponsored by Zealand Pharma and focuses on patients who rely on parenteral support (PS) due to reduced bowel length. Participants will receive either glepaglutide 10 mg or a placebo through subcutaneous injections twice a week. The trial includes a randomized treatment period followed by a long-term open-label safety phase. During the study, participants will be monitored closely to assess changes in their need for parenteral support and overall clinical response. Throughout the study, participants will undergo regular evaluations including measurement of parenteral support volume changes, clinical response assessments, and monitoring for treatment-emergent adverse events. The main outcome is the change in weekly parenteral support volume from baseline to week 24, with additional follow-ups up to week 52. Participants will be involved in scheduled visits and safety assessments during the entire study period, which runs until 2032.

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS