A Phase 3 interventional study of apraglutide in Short Bowel Syndrome, sponsored by VectivBio AG. Completed at 68 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by VectivBio AG (part of Ironwood Pharmaceuticals, Inc.) · Phase 3, Interventional, and Treatment
The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.
This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue.
The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's enrollment of 164 is above the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →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..
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Peptide analogue of GLP-2
Drug: apraglutide
Placebo for apraglutide, SC injection once weekly
Drug: apraglutide
Apraglutide is a 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.
Relative change from baseline in actual weekly PS volume at Week 24.
Time frame: At week 24 of treatment
Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only).
Time frame: Weeks 24 and 48 of treatment
Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).
Time frame: Weeks 12 / 24 / 48 of treatment
Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).
Time frame: Weeks 24 / 48 of treatment
At least 20% reduction of PS volume from baseline at Weeks 20 / 24.
Time frame: Weeks 20 / 24 of treatment
Calorie reduction in the PN at Weeks 24.
Time frame: Weeks 24 of treatment
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only)
Time frame: Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only)
Time frame: Weeks 24 / 48 of treatment.
Change from baseline on the Patient Global Impression of Treatment Satisfaction (PGI-TS) at week 24 and 48 (CIC only).
Time frame: Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) at Week 24 and 48 (CIC only).
Time frame: Weeks 24 / 48 of treatment
Change from baseline on the Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and 48 (CIC only).
Time frame: Weeks 24 / 48 of treatment
Absorption rate constant (ka) of apraglutide through population PK data analysis
Time frame: Weeks 0 / 24 of treatment
Apparent clearance (CL/F) of apraglutide through population PK data analysis
Time frame: Weeks 0 / 24 of treatment
Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis
Time frame: Weeks 0 / 24 of treatment
At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only)
Time frame: Weeks 20 / 24 of treatment
Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only)
Time frame: Weeks 24 / 48 of treatment
Ran from Jan 2021 to primary completion in Jan 2024, 35 months.
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 35 months is close to 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.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Apraglutide