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
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
Status
Active, not recruiting
Phase
Phase 3
Enrollment
158
Locations
66
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.
Full detailed description
This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 24, 2021
Study start
Jul 13, 2021
Primary completion
Oct 30, 2027
Study completion
Oct 30, 2027
Results posted
Not reported
Registry updated
Jul 2, 2025
Outcomes
What the study measures.
Primary outcomes
Adverse events (AE)
Time frame · From baseline to week 208
System organ class, frequency and severity
Clinical chemistry
Time frame · From baseline to week 208
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Hematology
Time frame · From baseline to week 208
Hematology panel of analytes will be examined for clinically significant changes.
Hemostasis
Time frame · From baseline to week 104
Hemostasis INR will be examined for clinically significant changes.
Urinalysis
Time frame · From baseline to week 208
Urinanalysis panel of analytes will be examined for clinically significant changes.
Occurrence of clinically relevant changes in vital signs
Time frame · From baseline to week 208
* Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes. * Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.
Occurrence of clinically relevant changes in electrocardiogram
Time frame · From baseline to week 208
ECG; intervals and rhythm
Secondary outcomes
Change from baseline in PS volume
Time frame · From baseline to week 208
Change from baseline in PS frequency
Time frame · From baseline to week 208
Change in PS days/week from baseline to week 104
Clinically significant changes in PS total energy
Time frame · From baseline to week 208
Units: kcal
Change from baseline in PS infusion time
Time frame · From baseline to week 208
Percentage of subjects reaching enteral autonomy
Time frame · From baseline to week 104
Change from baseline in body weight
Time frame · From baseline to week 104
Units: kg
Change from baseline on the Patient Global Impression of Severity (PGIS)
Time frame · From baseline to week 104
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)
Time frame · From baseline to week 208
Change from baseline on the Patient Global Impression of Change (PGIC)
Time frame · From baseline to week 208
Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)
Time frame · From baseline to week 208
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013 2. Able to give informed consent and agree to follow the details of participation as outlined in the protocol. Exclusion Criteria: 1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements. 2. Any other reason judged not eligible by the Investigator. 3. Pregnancy or lactation
Study locations
66 registered sites.
Argentina · Belgium · Czechia · Denmark · France · Germany · Hungary · Israel · Italy · Japan · Norway · Poland · South Korea · Spain · Sweden · Taiwan · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Northwestern University - Chicago
Chicago, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Washington Medical Center
Seattle, Washington, United States
University Hospital Fundacion Favaloro
Buenos Aires, Argentina
University Hospital Brussels
Brussels, Belgium
UZ Leuven
Leuven, Belgium
University Hospital Brno
Brno, Czechia
University Hospital Hradec Kralove
Hradec Králové, Czechia
Hospital Novy Jicin
Nový Jičín, Czechia
University Hospital Plzen
Pilsen, Czechia
University Hospital Kralovske Vinohrady
Prague, Czechia
General University Hospital in Prague
Prague, Czechia
Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases
Copenhagen, Denmark
Beaujon Hospital
Clichy, France
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Apraglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
Phase 2
Terminated
31
2025-10
A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
VectivBio AG · Hepatic Impairment
Phase 1
Completed
16
2025-07
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
VectivBio AG · Short Bowel Syndrome
Phase 2
Completed
10
2025-06
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
VectivBio AG · Short Bowel Syndrome
Phase 3
Completed
164
2024-11
Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support
GlyPharma Therapeutics · Short Bowel Syndrome
Phase 1 / Phase 2
Completed
8
2024-10
Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.
VectivBio AG · Chronic Kidney Disease
Phase 1
Completed
16
2024-10
Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation
VectivBio AG · Healthy Subjects
Phase 1
Completed
34
2024-10
Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency
GlyPharma Therapeutics · SBS - Short Bowel Syndrome
Phase 1 / Phase 2
Completed
8
2024-10
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.