Phase 3 Evaluation of Weekly Apraglutide Injections Compared to Placebo in Adults with Short Bowel Syndrome Associated with Intestinal Failure

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of apraglutide compared with a placebo in adults with short bowel syndrome associated with intestinal failure SBS-IF. This Phase 3, double-blind, randomized, placebo-controlled study aims to include about 124 adult participants who rely on parenteral support PS at least three days per week. Participants are stratified by anatomy and baseline PS volume to ensure balanced study groups. Participants will be randomly assigned to receive either weekly subcutaneous injections of apraglutide or placebo for 24 weeks. The study consists of four periods Screening including optimization and stabilization, Treatment, Safety Follow-up after the last dose, and an Anti-Drug Antibody Follow-up period. Those completing treatment may join a long-term extension study with apraglutide or complete a safety follow-up visit before entering the antibody monitoring phase. During the study, participants will have their weekly parenteral support volume measured to assess changes. Additional assessments include reductions in PS days per week, achievement of enteral autonomy, and patient-reported global impression of change. Safety will be monitored through adverse event tracking and laboratory tests. Participants are expected to adhere to fluid intake monitoring and may undergo colonoscopy or imaging to remove any polyps. The entire participation timeline extends beyond treatment to ensure thorough safety and immune response evaluation.

A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)