DRUG
apraglutide
Apraglutide is a 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.
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
Status
Completed
Phase
Phase 3
Enrollment
164
Locations
68
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.
Full detailed description
This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue. The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Nov 13, 2020
Study start
Jan 26, 2021
Primary completion
Jan 2, 2024
Study completion
Feb 22, 2024
Results posted
Not reported
Registry updated
Nov 27, 2024
Outcomes
What the study measures.
Primary outcomes
Relative change from baseline in actual weekly PS volume at Week 24.
Time frame · At week 24 of treatment
Secondary outcomes
Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only).
Time frame · Weeks 24 and 48 of treatment
Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).
Time frame · Weeks 12 / 24 / 48 of treatment
Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).
Time frame · Weeks 24 / 48 of treatment
At least 20% reduction of PS volume from baseline at Weeks 20 / 24.
Time frame · Weeks 20 / 24 of treatment
Calorie reduction in the PN at Weeks 24.
Time frame · Weeks 24 of treatment
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only)
Time frame · Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only)
Time frame · Weeks 24 / 48 of treatment.
Change from baseline on the Patient Global Impression of Treatment Satisfaction (PGI-TS) at week 24 and 48 (CIC only).
Time frame · Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) at Week 24 and 48 (CIC only).
Time frame · Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and 48 (CIC only).
Time frame · Weeks 24 / 48 of treatment
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria 1. Signed informed consent for this trial prior to any trial specific assessment. 2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC). 3. Subject must require PS at least 3 days per work and be considered stable. 4. No restorative surgery intended to change PS requirements in the trial period. 5. Age ≥18 years at screening. Exclusion Criteria: 1. Pregnancy or lactation. 2. Major abdominal surgery in the last 6 months prior to screening. 3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer. 4. Evidence of active inflammatory GI conditions in the previous 6 months. 5. Evidence of decompensated heart failure. 6. Evidence of severe renal or hepatic impairment. 7. Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.
Study locations
68 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, Illinois, United States
Henry Ford Medical Center - Columbus
Novi, Michigan, United States
Mayo Clinic
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 Hospital
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, Center for Human Nutrition
Nashville, Tennessee, United States
University of Washington Medical Center
Seattle, Washington, United States
University Hospital Foundation Favaloro
Buenos Aires, Argentina
Universitair Ziekenhuis Leuven - Gasthuisberg
Leuven, Vlaams Brabant, Belgium
University Hospital Brussels
Brussels, 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, 2nd Internal Clinic
Prague, Czechia
General University Hospital in Prague
Prague, Czechia
Rigshospitalet - University Hospital Copenhagen
Copenhagen, Denmark
Hôpital Beaujon
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
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
VectivBio AG · Short Bowel Syndrome
Phase 3
Active, not recruiting
158
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
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.
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