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

Short Bowel Syndrome Clinical Trial

— STARSnutrition  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964986
• Other study ID #: TA799-013
• Status: Completed
• Phase: Phase 2
• Start date: June 14, 2021
• Est. completion date: June 6, 2023

Study information

• Verified date: August 2023
• Source: VectivBio AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Failure
• Short Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
France	Beaujon Hospital	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
VectivBio AG

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

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