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

Phase 2

Completed

• Conditions: Short Bowel Syndrome
• Interventions: Drug: Apraglutide

• Registration Number: NCT04964986
• Lead Sponsor: VectivBio AG

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-05-27
• Study Start: 2021-06-14
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-16
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Status Verified: 2023-08
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apraglutide SC injections, once weekly	Apraglutide	Peptide analogue of GLP-2

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in urinary calcium as assessed by atomic absorption spectrometry	From Baseline at weeks 4 and 48	Units: mmol/day
Relative change from baseline in actual weekly PS volume	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 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
Changes in urinary potassium as assessed by flame photometry	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
Absolute change from baseline in actual weekly PS volume	Weeks 24 and 52
Clinical responders (20% reduction of PS volume from baseline)	Weeks 24 and 52
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
Subjects who achieve a reduction of at least 1 day per week of PS	From Baseline at weeks 24 and 52
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 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 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 carbohydrate derived as the difference between oral intake and excretion	From Baseline at week 4 and at week 48	Assessed by Englyst's method
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 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 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

Trial Locations

Locations (2)

Beaujon Hospital; 🇫🇷 Clichy, France

UZ Leuven; 🇧🇪 Leuven, Belgium