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Active, not recruitingNCT05018286STARS extendUpdated Jul 2, 2025

Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

A Phase 3 interventional study of Apraglutide in Short Bowel Syndrome, sponsored by VectivBio AG. Active, not recruiting at 66 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-02.

Sponsored by VectivBio AG (part of Ironwood Pharmaceuticals, Inc.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
158
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

Read the detailed description

This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.

02

Conditions studied

  • Short Bowel Syndrome

Keywords

  • Short Bowel Syndrome
  • SBS
  • Intestinal Failure
  • SBS-IF
03

In context

Short Bowel Syndrome

159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.

This study's enrollment of 158 is above the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.

Browse Short Bowel Syndrome studies →

Lead sponsor

VectivBio AG is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

First submitted before VectivBio AG became part of Ironwood Pharmaceuticals, Inc..

Browse VectivBio AG studies →All Ironwood Pharmaceuticals, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Able to give and agree to follow the details of participation as outlined in the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
  2. Any other reason judged not eligible by the Investigator.
  3. Pregnancy or lactation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
158 participants (actual)

Study arms

  • Experimental
    Apraglutide subcutaneous (SC) injections, once weekly

    Peptide analogue of Glucagon-like Peptide 2 (GLP-2)

    Drug: Apraglutide

Interventions

  • DrugApraglutide

    Apraglutide is a synthetic 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

06

What researchers measure

Primary outcomes

  1. Adverse events (AE)

    System organ class, frequency and severity

    Time frame: From baseline to week 208

  2. Clinical chemistry

    Clinical Chemistry panel of analytes will be examined for clinically significant changes.

    Time frame: From baseline to week 208

  3. Hematology

    Hematology panel of analytes will be examined for clinically significant changes.

    Time frame: From baseline to week 208

  4. Hemostasis

    Hemostasis INR will be examined for clinically significant changes.

    Time frame: From baseline to week 104

  5. Urinalysis

    Urinanalysis panel of analytes will be examined for clinically significant changes.

    Time frame: From baseline to week 208

  6. Occurrence of clinically relevant changes in vital signs

    * Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes. * Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.

    Time frame: From baseline to week 208

  7. Occurrence of clinically relevant changes in electrocardiogram

    ECG; intervals and rhythm

    Time frame: From baseline to week 208

Secondary outcomes

  1. Change from baseline in PS volume

    Time frame: From baseline to week 208

  2. Change from baseline in PS frequency

    Change in PS days/week from baseline to week 104

    Time frame: From baseline to week 208

  3. Clinically significant changes in PS total energy

    Units: kcal

    Time frame: From baseline to week 208

  4. Change from baseline in PS infusion time

    Time frame: From baseline to week 208

  5. Percentage of subjects reaching enteral autonomy

    Time frame: From baseline to week 104

  6. Change from baseline in body weight

    Units: kg

    Time frame: From baseline to week 104

  7. Change from baseline on the Patient Global Impression of Severity (PGIS)

    Time frame: From baseline to week 104

  8. Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)

    Time frame: From baseline to week 208

  9. Change from baseline on the Patient Global Impression of Change (PGIC)

    Time frame: From baseline to week 208

  10. Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)

    Time frame: From baseline to week 208

  11. Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)

    Time frame: From baseline to week 208

  12. Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)

    Time frame: From baseline to week 208

  13. Change from baseline on the Short Form (36) Health Survey (SF-36)

    Time frame: From baseline to week 208

  14. Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)

    Time frame: From baseline to week 208

07

Study locations

66 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Oct 2027, 75 months after the start.

Of 26 industry-sponsored phase 3 interventional studies under Short Bowel Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 45. This study's planned 75 months is above that.

Counting every sponsor, half of 27 studies reached it within 37 months; a quarter within 24 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2021
First posted
Aug 24, 2021
StartActual
Jul 13, 2021
Primary completionEst.
Oct 30, 2027
CompletionEst.
Oct 30, 2027
Last update
Jul 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05018286
Lead sponsor
VectivBio AG
Responsible party
Sponsor
First posted
Aug 24, 2021
Start date
Jul 13, 2021
Primary completion
Oct 30, 2027 (estimated)
Completion
Oct 30, 2027 (estimated)
Last update
Jul 2, 2025

Study contacts

Tomasz Masior
study director · VectivBio AG

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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