Apraglutide for Short Bowel Syndrome

(STARS Trial)

Recruiting at 79 trial locations

Overseen By Fritze

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VectivBio AG

Must not be taking: Growth factors

Disqualifiers: Pregnancy, Cancer, Heart failure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

164 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, any previous use of growth factors like growth hormone or GLP-2 analogues should be discussed with the investigator.

What data supports the effectiveness of the drug Apraglutide for Short Bowel Syndrome?

Research shows that Apraglutide, a drug similar to other treatments like teduglutide, helps improve fluid and nutrient absorption in patients with short bowel syndrome. This means it can potentially reduce the need for additional nutritional support. ^{1 2 3 4 5}

Is Apraglutide safe for humans?

Apraglutide has been studied for safety in patients with short bowel syndrome, and the trials suggest it is generally safe for human use, focusing on improving fluid and nutrient absorption. ^{1 4 6 7 8}

How is the drug Apraglutide different from other treatments for short bowel syndrome?

Apraglutide is unique because it is a long-acting glucagon-like peptide-2 (GLP-2) analog designed for once-weekly subcutaneous (under the skin) dosing, which helps improve fluid and nutrient absorption in patients with short bowel syndrome. This contrasts with other treatments like teduglutide, which may require more frequent dosing. ^{1 2 4 5 9}

Research Team

Tomasz Masior

Principal Investigator

VectivBio AG

Eligibility Criteria

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.

Inclusion Criteria

Subject must require PS at least 3 days per work and be considered stable.

No restorative surgery intended to change PS requirements in the trial period.

Signed informed consent for this trial prior to any trial specific assessment.

Exclusion Criteria

You have had a flare up of inflammatory bowel disease or other gastrointestinal conditions in the past 6 months.

If you have ever used growth hormones or similar medications before, you will need to talk with the researcher before joining the study.

History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly subcutaneous injections of apraglutide or placebo for 48 weeks

48 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Apraglutide

Trial Overview 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.

Participant Groups

Group I: Apraglutide SC injections, once weekly Experimental Treatment 1 Intervention

Peptide analogue of GLP-2

Group II: Placebo Placebo Group 1 Intervention

Placebo for apraglutide, SC injection once weekly

Who Is Running the Clinical Trial?

VectivBio AG

Lead Sponsor

Trials

11

Recruited

490+

References

1. United States pubmed.ncbi.nlm.nih.gov

Apraglutide, a novel once-weekly glucagon-like peptide-2 analog, improves intestinal fluid and energy absorption in patients with short bowel syndrome: An open-label phase 1 and 2 metabolic balance trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Apraglutide, a novel glucagon-like peptide-2 analog, improves fluid absorption in patients with short bowel syndrome intestinal failure: Findings from a placebo-controlled, randomized phase 2 trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes With Teduglutide From a Single Center. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Modern treatment of short bowel syndrome. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Treatment with Liraglutide Early after Surgical Intervention on Clinical Outcomes in Patients with Short Bowel Syndrome: A Pilot Observational "Real-Life" Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety Findings in Pediatric Patients During Long-Term Treatment With Teduglutide for Short-Bowel Syndrome-Associated Intestinal Failure: Pooled Analysis of 4 Clinical Studies. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Teduglutide in Infants and Children With Short Bowel Syndrome Dependent on Parenteral Support. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial. [2020]