What side effects are associated with this type of intervention?

Common treatments for Short Bowel Syndrome (SBS) include GLP-2 analogs like teduglutide, which enhance intestinal absorption. Known side effects of GLP-2 analogs include abdominal pain, nausea, vomiting, injection site reactions, and potential fluid overload. Other treatments for SBS, such as parenteral nutrition, can lead to complications like infections, liver disease, and metabolic bone disease. It is important to monitor patients closely for these side effects and adjust treatment as necessary.

What prior FDA approvals exist?

The FDA has previously approved Teduglutide (brand name Gattex) for the treatment of Short Bowel Syndrome. Teduglutide is a GLP-2 analog that enhances intestinal absorption, similar to Apraglutide. It works by promoting the growth and function of the remaining intestinal lining, thereby improving nutrient absorption and reducing the need for parenteral support.

What other types of research exist?

Promising alternatives to Apraglutide for Short Bowel Syndrome patients include GLP-1 receptor agonists such as liraglutide and semaglutide, which have shown benefits in gastrointestinal motility and absorption. Additionally, other novel therapies in clinical trials targeting intestinal absorption and gut health may also be considered.

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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 up to 5 years

Awards & highlights

Summary

This trial tests if apraglutide, an injection given regularly, can help adults with Short Bowel Syndrome absorb more nutrients and reduce their need for intravenous feeding. Apraglutide is designed to improve fluid and nutrient absorption in these patients.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Short Bowel Syndrome (SBS) include GLP-2 analogs like Apraglutide, which enhance intestinal absorption by promoting mucosal growth, increasing villus height, and improving gut barrier function. This is particularly important for SBS patients as they have a significantly reduced intestinal surface area, leading to malabsorption and nutrient deficiencies. By enhancing the absorptive capacity of the remaining intestine, GLP-2 analogs help reduce dependence on parenteral nutrition and improve overall nutritional status.

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

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