Phase 3 Study of Daily Subcutaneous Teduglutide for 24 Weeks in Chinese Adults With Short Bowel Syndrome Dependent on Parenteral Support

What this Trial Is About

Researchers are evaluating how well teduglutide works in Chinese adults with short bowel syndrome SBS who depend on parenteral support. The study aims to see how much teduglutide can reduce the need for parenteral support and to understand how the body absorbs, processes, and clears the drug. This is a Phase 3, open-label study focused on treatment outcomes over 24 weeks. Participants will receive a daily injection of teduglutide at a dose of 0.05 mg per kilogram under the skin, injected into one of four areas on the abdomen, thigh, or arm. The treatment period lasts 24 weeks, followed by a safety monitoring phase that continues for another 24 weeks. The entire study duration for each participant is about 65 weeks. During the study, participants will be regularly assessed for changes in their weekly parenteral support volume, safety, and how teduglutide moves through the body. Tests include blood plasma measurements, urine output, body weight, and monitoring for any adverse events. Researchers will closely track treatment effects and safety up to 48 weeks after the initial treatment period to understand long-term impacts.

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome