Phase 2 Trial of Weekly FT1 Injections Compared to Placebo for Adults with Short Bowel Syndrome

What this Trial Is About

Researchers are investigating the safety and effects of FT1 injections in adults with short bowel syndrome SBS, a condition caused by surgical removal of part of the small intestine. This phase 2 trial compares FT1 to a placebo to understand how well FT1 works and how it behaves in the body. The study uses a crossover design where participants receive both treatments separated by a washout period. Participants receive weekly subcutaneous injections of FT1 or placebo for 5 weeks, followed by at least a 6-week washout period, then switch to the other treatment for another 5 weeks. Each cycles effectiveness is assessed by a 72-hour metabolic balance study, measuring changes in fecal wet weight and other markers. The study is double-blind and randomized to ensure unbiased results. During the study, participants attend clinic visits for assessments including metabolic balance studies, blood tests measuring plasma concentrations and biomarkers, and monitoring for adverse events. Outcomes measured include treatment safety, changes in fecal and urine volumes, and plasma levels of L-citrulline. The total participation period spans approximately 5 months from the first dose to study completion, with close safety monitoring throughout.

A Clinical Study of FT1 in Patients With Short Bowel Syndrome