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

Sponsor

VectivBio AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04964986

Collaborator

(none)

Enrollment

Locations

Arm

30.5

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Short Bowel Syndrome	Drug: Apraglutide	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Jun 14, 2021

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Apraglutide SC injections, once weekly Peptide analogue of GLP-2	Drug: 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.

Arm

Intervention/Treatment

Experimental: Apraglutide SC injections, once weekly

Peptide analogue of GLP-2

Drug: 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.

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability of apraglutide [From baseline to week 48]
Assessed by: Adverse events (AEs; system organ class, frequency and severity) Adverse events of special interest (AESIs): Injection site reaction Gastrointestinal obstruction Gallbladder, biliary and pancreatic disease Fluid overload Colorectal polyps Malignancies Clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADA), and urine analysis

Secondary Outcome Measures

Relative change from baseline in actual weekly PS volume [Weeks 24 and 52]
Absolute change from baseline in actual weekly PS volume [Weeks 24 and 52]
Subjects who achieve a reduction of at least 1 day per week of PS [From Baseline at weeks 24 and 52]
Clinical responders (20% reduction of PS volume from baseline) [Weeks 24 and 52]
Subjects reaching enteral autonomy as assessed by the need or reduction of parenteral support requirements. [Weeks 24 and 52]
Energy reduction in the Parenteral Nutrition as assessed by parenteral support calorie content [From Baseline at weeks 24 and 52]
Units: Cal/week
Change in absolute energy absorption assessed by the difference between oral intake and excretion [From Baseline to week 48]
Assessed by bomb calorimetry Units: Cal/gr
Relative change in absorption of energy derived as the difference between oral intake and excretion. [From Baseline at week 4 and at week 48]
Assessed by bomb calorimetry
Relative change in absorption of carbohydrate derived as the difference between oral intake and excretion [From Baseline at week 4 and at week 48]
Assessed by Englyst's method
Relative change in absorption of nitrogen derived as the difference between oral intake and excretion [From Baseline at week 4 and at week 48]
Assessed by Kjeldahl's method
Relative change in absorption of lipid derived as the difference between oral intake and excretion [From Baseline at week 4 and at week 48]
Assessed by modified Van de Kamer titration technique
Change in absolute absorption of energy over metabolic balance periods to assess changes in nutrient absorption of intestinal output [From Baseline at week 4 and at week 48]
Assessed by bomb calorimetry Units: Cal/day
Change in absolute absorption of carbohydrate, over metabolic balance periods [From Baseline at week 4 and at week 48]
Assessed by Englyst's method Units: kJ/day
Change in absolute absorption of nitrogen, over metabolic balance periods [From Baseline at week 4 and at week 48]
Assessed by Kjeldahl's method Units: kJ/day
Change in absolute absorption of lipid, over metabolic balance periods [From Baseline at week 4 and at week 48]
Assessed by modified Van de Kamer titration technique Units: kJ/day
Changes in urine output over metabolic balance periods. [From Baseline at weeks 4 and 48]
Units: L/day
Changes in urinary sodium as assessed by flame photometry [From Baseline at weeks 4 and 48]
Units: mmol/day
Changes in urinary potassium as assessed by flame photometry [From Baseline at weeks 4 and 48]
Units: mmol/day
Changes in urinary calcium as assessed by atomic absorption spectrometry [From Baseline at weeks 4 and 48]
Units: mmol/day
Changes in urinary magnesium as assessed by atomic absorption spectrometry [From Baseline at weeks 4 and 48]
Units: mmol/day

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 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.