← Back to Search

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

Apraglutide for Short Bowel Syndrome (STARS 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12 / 24 / 48 of treatment
Awards & highlights

STARS Trial Summary

This trial is testing if apraglutide is effective in reducing the need for parenteral support (getting nutrients through an IV).

Who is the study for?
This trial is for adults over 18 with Short Bowel Syndrome-Intestinal Failure who need parenteral support at least 3 days a week and are stable. They shouldn't plan any restorative gut surgery during the trial, have had recent major abdominal surgery, inflammatory GI conditions, severe organ impairment, or cancer within the last 5 years.Check my eligibility
What is being tested?
The trial tests apraglutide's effectiveness in reducing dependency on parenteral support (PS) among patients with SBS-IF. Participants will receive weekly subcutaneous injections of apraglutide to see if it can help reduce their need for PS.See study design
What are the potential side effects?
While specific side effects of apraglutide aren't listed here, similar medications often cause digestive issues like nausea or diarrhea, injection site reactions, and potential changes in blood sugar levels.

STARS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12 / 24 / 48 of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12 / 24 / 48 of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative change from baseline in actual weekly PS volume at Week 24.
Secondary outcome measures
Absorption rate constant (ka) of apraglutide through population PK data analysis
Apparent clearance (CL/F) of apraglutide through population PK data analysis
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis
+12 more

STARS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Apraglutide SC injections, once weeklyExperimental Treatment1 Intervention
Peptide analogue of GLP-2
Group II: PlaceboPlacebo Group1 Intervention
Placebo for apraglutide, SC injection once weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
apraglutide
2021
Completed Phase 3
~170

Find a Location

Who is running the clinical trial?

VectivBio AGLead Sponsor
10 Previous Clinical Trials
322 Total Patients Enrolled
4 Trials studying Short Bowel Syndrome
183 Patients Enrolled for Short Bowel Syndrome
BolognaniStudy DirectorVectivBio AG
5 Previous Clinical Trials
259 Total Patients Enrolled
2 Trials studying Short Bowel Syndrome
167 Patients Enrolled for Short Bowel Syndrome
SeabrookStudy DirectorVectivBio AG
2 Previous Clinical Trials
167 Total Patients Enrolled
2 Trials studying Short Bowel Syndrome
167 Patients Enrolled for Short Bowel Syndrome

Media Library

Apraglutide (Glucagon-like peptide-2 (GLP-2) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04627025 — Phase 3
Short Bowel Syndrome Research Study Groups: Placebo, Apraglutide SC injections, once weekly
Short Bowel Syndrome Clinical Trial 2023: Apraglutide Highlights & Side Effects. Trial Name: NCT04627025 — Phase 3
Apraglutide (Glucagon-like peptide-2 (GLP-2) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04627025 — Phase 3
~38 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top