NCT04964986

Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)

A Multicenter, Open-label, Metabolic Balance Study to Evaluate the Effects of Apraglutide on Intestinal Absorption in Adult Subjects With Short Bowel Syndrome, Intestinal Failure (SBS-IF), and Colon-in-Continuity (CIC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: VectivBio AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.

Detailed description

This is an international, multicenter trial to evaluate the safety of apraglutide in adult participants with SBS-IF and CIC. The active pharmaceutical ingredient is apraglutide, an investigational glucagon-like peptide-2 (GLP-2) analogue. The trial consists of an evaluation period of 52 weeks.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Apraglutide	Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2021-07-16
• Last updated: 2025-06-18
• Results posted: 2025-06-18

Locations

2 sites across 2 countries: Belgium, France

Regulatory

• FDA-regulated drug study