NCT06973304

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

An Open-label, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of 0.05 mg/kg/Day Subcutaneous Teduglutide Following Treatment of Short Bowel Syndrome for 24 Weeks in Chinese Adults Who Are Dependent on Parenteral Support

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the study is to assess how well teduglutide works over 24 weeks in Chinese adult participants with short bowel syndrome (SBS) who need parenteral support and to see how much it can reduce the amount of parenteral support and understand how the body absorbs, processes, and gets rid of teduglutide. Participants will receive a daily injection of teduglutide under the skin for 24 weeks. Safety of teduglutide will be checked for 24 weeks after treatment. Participants will be in the study for about 65 weeks.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Teduglutide	Teduglutide 0.05 mg/kg SC injection.

Timeline

• Start date: 2025-06-26
• Primary completion: 2027-02-10
• Completion: 2027-07-28
• First posted: 2025-05-15
• Last updated: 2025-07-09

Locations

4 sites across 1 country: China