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

NCT04964986 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: TA799-0132020-005129-99
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Short Bowel Syndrome

Keywords

Intestinal Failure; SBS; SBS-IF; CIC; Colon-in-Continuity

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)

  A TEAE was any unfavorable and unintended sign, symptom, or disease temporally associated with apraglutide, whether or not related, that occurred or worsened after the dose of apraglutide. A serious TEAE was defined as any TEAE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. Clinically significant changes from baseline in clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADAs), and urine analysis were reported as adverse events. Adverse events of special interest (AESI) included injection site reaction, gastrointestinal obstruction, gallbladder, biliary, and pancreatic disease, fluid overload, colorectal polyps, malignancies.

  Day 1 up to approximately 55 weeks

• Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48

  Applicable to Protocol V3.0 implemented in France (classed as secondary endpoint in Protocol V4.0 \[implemented in Belgium\]). The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.

  Baseline and Week 48

Secondary Outcomes (18)

• Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52

  Baseline, Week 4, Week 24, and Week 52

• Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52

  Baseline, Week 24 and Week 52

• Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52

  Baseline, Week 24 and Week 52

• Number of Participants Considered Clinical Responders at Weeks 24 and 52

  Baseline, Week 24 and 52

• Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52

  Weeks 24 and 52

Study Arms (1)

Apraglutide

EXPERIMENTAL

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

Drug: Apraglutide

Interventions

Apraglutide 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.

Also known as: TA799

Apraglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VectivBio AG: lead

Study Sites (2)

UZ Leuven

Leuven, 3000, Belgium

Location

Beaujon Hospital

Clichy, 92110, France

Location

Related Publications (1)

• Verbiest A, Hvistendahl MK, Bolognani F, Li C, Youssef NN, Huh S, Menys A, Bhatnagar G, Vanslembrouck R, Peeters R, Sartoris R, Vermeersch P, Wauters L, Verbeke K, Jeppesen PB, Joly F, Vanuytsel T. Efficacy and safety of apraglutide in short bowel syndrome with intestinal failure and colon-in-continuity: A multicenter, open-label, metabolic balance study. Clin Nutr. 2024 Dec;43(12):158-166. doi: 10.1016/j.clnu.2024.10.011. Epub 2024 Oct 16.

  PMID: 39461299 DERIVED

MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Failure

Interventions

apraglutide

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Information Desk
• Organization: VectivBio AG

ClinicalTrialEnquiries@ironwoodpharma.com

617.621.7722

Study Officials

• Tomasz Masior

  VectivBio AG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: July 16, 2021
• Study Start: June 14, 2021
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Locations

BE (1); FR (1)