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)

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

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.

Inclusion Criteria:

• Signed informed consent for this trial prior to any trial specific assessment.
• Male and female subjects with SBS-IF and CIC, receiving parenteral support (PS), secondary to surgical resection of the small intestine with < 200 cm from duodenojejunal flexure.
• Subject must require parenteral support (PS) at least 2 days per week and be considered stable.
• No restorative surgery intended to change PS requirements in the trial period.
• Age ≥ 18 years at screening.

Exclusion Criteria:

• Pregnancy or lactation.
• Body mass index equal or higher than 30 kg/m^2 at the time of screening.
• Major abdominal surgery in the last 6 months prior to screening.