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Glucagon-like peptide-2 (GLP-2) agonist

Long-Term Safety of Apraglutide for Short Bowel Syndrome (STARS extend Trial)

Phase 3
Waitlist Available
Research Sponsored by VectivBio AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 208
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests a drug to see if it's safe and if people with short bowel syndrome can tolerate it in the long-term.

Who is the study for?
This trial is for men and women with Short Bowel Syndrome (SBS) due to surgery, who were previously in trials TA799-007 or TA799-013. Participants must be able to consent and follow the study plan. Those unable to understand the requirements, unwilling to adhere to visit schedules, pregnant or lactating individuals are excluded.
What is being tested?
The trial is testing Apraglutide's long-term safety for people with SBS. It's an open-label extension which means everyone knows they're getting Apraglutide and there’s no placebo group involved.
What are the potential side effects?
While specific side effects of Apraglutide aren't listed here, common ones may include digestive issues like nausea or diarrhea, injection site reactions, and potential changes in nutrient absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was part of previous trials TA799-007 or TA799-013 and have SBS-IF due to surgery on my small intestine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I understand and agree to follow the trial's schedule and requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 208
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 208 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events (AE)
Clinical chemistry
Hematology
+4 more
Secondary study objectives
Change from baseline in PS frequency
Change from baseline in body weight
Clinically significant changes in PS total energy

Side effects data

From 2021 Phase 1 trial • 16 Patients • NCT04699032
13%
Chest pain
13%
Blood creatinine increased
13%
Injection site hemorrhage
13%
Injection site papule
13%
Nausea
13%
Vomiting
13%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Severely Impaired Renal Function
Normal Renal Function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Apraglutide subcutaneous (SC) injections, once weeklyExperimental Treatment1 Intervention
Peptide analogue of Glucagon-like Peptide 2 (GLP-2)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apraglutide
2023
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

VectivBio AGLead Sponsor
10 Previous Clinical Trials
328 Total Patients Enrolled
4 Trials studying Short Bowel Syndrome
189 Patients Enrolled for Short Bowel Syndrome
Tomasz MasiorStudy DirectorVectivBio AG
9 Previous Clinical Trials
297 Total Patients Enrolled
4 Trials studying Short Bowel Syndrome
189 Patients Enrolled for Short Bowel Syndrome
SeabrookStudy DirectorVectivBio AG
2 Previous Clinical Trials
173 Total Patients Enrolled
2 Trials studying Short Bowel Syndrome
173 Patients Enrolled for Short Bowel Syndrome
BolognaniStudy DirectorVectivBio AG
5 Previous Clinical Trials
265 Total Patients Enrolled
2 Trials studying Short Bowel Syndrome
173 Patients Enrolled for Short Bowel Syndrome

Media Library

Apraglutide (Glucagon-like peptide-2 (GLP-2) agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05018286 — Phase 3
Short Bowel Syndrome Research Study Groups: Apraglutide subcutaneous (SC) injections, once weekly
Short Bowel Syndrome Clinical Trial 2023: Apraglutide Highlights & Side Effects. Trial Name: NCT05018286 — Phase 3
Apraglutide (Glucagon-like peptide-2 (GLP-2) agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018286 — Phase 3
~70 spots leftby Oct 2027
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