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Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

NCT05018286 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2025-07-02

No results posted yet for this study

Summary

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

Conditions

  • Short Bowel Syndrome

Interventions

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

Sponsors & Collaborators

  • VectivBio AG

    lead INDUSTRY

Principal Investigators

  • Tomasz Masior · VectivBio AG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2027-10-30
Completion
2027-10-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Norway
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05018286 on ClinicalTrials.gov