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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2023-06-06

Brief Summary

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

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Detailed Description

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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

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Short Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apraglutide

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

Group Type EXPERIMENTAL

Apraglutide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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TA799

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No