Trial Registered

Peg-Bio opens 8-patient Phase 2 test of FT1 in short bowel syndrome

The trial measures fecal wet weight against baseline in a metabolic balance study, entering a field where GLP-2 drugs already dominate.

By AppliedXLJuly 15, 2026Trial NCT07704047

Executive Summary

A Chinese biopharma company has opened a small, mechanistic Phase 2 study of an oral or injectable candidate in short bowel syndrome, built around a metabolic-balance measure rather than a clinical outcome.
The design tests whether the drug changes fecal fluid loss and a related pharmacodynamic marker, a signal that would need much larger confirmation before it says anything about clinical benefit.
The candidate enters a field where GLP-2 receptor agonists already lead in Phase 3 testing for the same indication, including one from the same sponsor, which narrows the room for a new mechanism to differentiate.
The sponsor has completed every trial it has previously run, an execution record that says nothing about whether this particular mechanism will work but does bear on operational credibility.

The trial

NCT07704047 is a Phase 2 interventional study of FT1 in patients with short bowel syndrome (SBS), a condition in which surgical resection of the small intestine leaves patients unable to absorb enough fluid and nutrients, often requiring long-term parenteral support. The trial targets eight patients in China and uses a crossover design, with two five-week treatment cycles separated by at least a six-week washout. It is expected to start August 30, 2026, and reach primary completion April 15, 2027, a roughly eight-month window from first dose to final readout. NCT07704047

The endpoint bar

The registered primary endpoint is the change in fecal wet weight from baseline to the end of treatment, measured in a 72-hour metabolic balance study at the end of the second treatment cycle. A co-primary measure tracks treatment-related adverse events graded by NCI-CTCAE version 6.0 criteria. Secondary measures include plasma L-citrulline, a pharmacodynamic marker of intestinal absorptive capacity, urine volume, and standard pharmacokinetic parameters (Cmax, AUC). Enrollment requires patients with an average daily fecal wet output of at least 800 grams at baseline and stable parenteral-support needs for 14 days before randomization, a design meant to isolate drug effect from routine variability in a small sample. NCT07704047

Where it sits in the field

Short bowel syndrome's most advanced pharmacology runs through GLP-2 receptor agonists: Takeda's teduglutide, Zealand Pharma's glepaglutide, and VectivBio's apraglutide all sit in Phase 3 testing for the same indication, with parenteral-support volume reduction as their common endpoint. Peg-Bio itself already runs a Phase 3 GLP-2 receptor program, PJ009, in the same indication. FT1's target and mechanism are not established in available records, so this trial's competitive position rests on its endpoint choice rather than its molecular class: a fecal-weight and citrulline pharmacodynamic readout is a different measurement strategy than the parenteral-support endpoints the GLP-2 field has converged on. NCT07704047

Execution context

Peg-Bio has completed all five of its previously tracked trials, with none terminated, and currently runs eleven trials across Recruiting and Completed status. The new trial carries no protocol amendments beyond its initial registration and no enrollment changes to evaluate, since it has not yet opened for recruitment. NCT07704047

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.