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

Launched by VECTIVBIO AG · Jul 6, 2021

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility 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.