Metabolic Balance Study of Apraglutide in Patients With SBS-IF and Colon-in-Continuity

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the trial is to evaluate the efficacy of apraglutide in increasing intestinal energy absorption in relation to metabolic balance assessments.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VectivBio AG

Criteria

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 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/m2 at the time of screening.

• Major abdominal surgery in the last 6 months prior to screening.