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

VectivBio

Status and phase: Completed; Phase 2

Conditions: Short Bowel Syndrome

Treatments: Drug: Apraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04964986

2020-005129-99 (EudraCT Number)

TA799-013

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Apraglutide

Experimental group

Description:

All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks.

Treatment:

Drug: Apraglutide