A Phase 2 interventional study of Apraglutide in Short Bowel Syndrome, sponsored by VectivBio AG. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by VectivBio AG (part of Ironwood Pharmaceuticals, Inc.) · Phase 2, Interventional, and Treatment
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.
This is an international, multicenter trial to evaluate the safety of apraglutide in adult participants with SBS-IF and CIC. The active pharmaceutical ingredient is apraglutide, an investigational glucagon-like peptide-2 (GLP-2) analogue. The trial consists of an evaluation period of 52 weeks.
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's enrollment of 10 is below 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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks.
Drug: Apraglutide
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.
Also known as: TA799
Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)
A TEAE was any unfavorable and unintended sign, symptom, or disease temporally associated with apraglutide, whether or not related, that occurred or worsened after the dose of apraglutide. A serious TEAE was defined as any TEAE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. Clinically significant changes from baseline in clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADAs), and urine analysis were reported as adverse events. Adverse events of special interest (AESI) included injection site reaction, gastrointestinal obstruction, gallbladder, biliary, and pancreatic disease, fluid overload, colorectal polyps, malignancies.
Time frame: Day 1 up to approximately 55 weeks
Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48
Applicable to Protocol V3.0 implemented in France (classed as secondary endpoint in Protocol V4.0 \[implemented in Belgium\]). The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
Time frame: Baseline and Week 48
Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52
The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.
Time frame: Baseline, Week 4, Week 24, and Week 52
Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52
The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.
Time frame: Baseline, Week 24 and Week 52
Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52
Participants were considered to have a reduction of at least one day per week of PS from Baseline (incl. extra fluids) if the number of days with PS from weekly PS diary data recorded for the corresponding analysis timepoint was smaller compared to the number of days with PS from weekly PS diary data for Baseline.
Time frame: Baseline, Week 24 and Week 52
Number of Participants Considered Clinical Responders at Weeks 24 and 52
Clinical response was defined as a 20% reduction of PS volume from Baseline. The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.
Time frame: Baseline, Week 24 and 52
Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52
Enteral autonomy was defined as a participant not receiving PS for hydration or parenteral nutrition (PN) for calories. Participants may have still receive minimal fluid to maintain patency of the central line or for specific elemental/micro-nutrient needs (e.g., \<100 mL fluid for administration of magnesium).
Time frame: Weeks 24 and 52
Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52
PN was defined as PS that includes protein, carbohydrate, fat, vitamins, and/or trace elements.
Time frame: Baseline, Week 24 and Week 52
Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
Time frame: Baseline and Week 48
Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
Time frame: Baseline, Week 4 and Week 48
Absolute Change in Urine Volume Over MB Periods From Baseline at Week 4 and Week 48
Based on average daily urine volume data derived as per balance period calculations.
Time frame: Baseline, Week 4 and Week 48
Absolute Change in Absorption of Energy Over MB Periods From Baseline at Week 4
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
Time frame: Baseline and Week 4
Absolute Change in Urinary Electrolytes Over MB Periods From Baseline at Week 4 and Week 48
Since urinary electrolytes data were measured over the 72-hour MB period, the average of all available results were used for analyses for each MB parameter at a given analysis time point.
Time frame: Baseline, Week 4 and Week 48
Change From Baseline in Pittsburgh Sleep Quality Inventory (PSQI) Total Score at Week 24 and Week 52
The PSQI is a patient-reported questionnaire used to measure the quality and patterns of sleep, over the past month. The PSQI has seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Minimum Score = 0 (better); Maximum Score = 21 (worse). A negative change from baseline represents an reduction in symptoms.
Time frame: Baseline, Week 24 and Week 52
Change From Baseline in Patient Global Impression of Change (PGIC) at Week 24 and Week 52
PGIC v2.0 is a single-item questionnaire using a 5-point verbal rating scale, to assess overall change in the participants status after taking the study drug. Response options range from 2= very much better to -2= very much worse.
Time frame: Baseline, Week 24 and Week 52
Secondary: Patient Global Impression of Treatment Satisfaction (PGI-TS) at Week 24 and Week 52
This form is a single-item questionnaire assessing the participant's satisfaction with the trial medication over the preceding 7 days. Response options range from -2 to 2, very dissatisfied to very satisfied.
Time frame: Week 24 and Week 52
Change From Baseline in Patient Global Impression of Satisfaction With Parenteral Support (PGI-SPS) at Week 24 and Week 52
This is a single-item questionnaire assessing the participant's satisfaction with PS over the preceding 7 days. Response options range from -2 to 2, very dissatisfied to very satisfied. A reduction from baseline represents a decrease in satisfaction.
Time frame: Baseline, Week 24 and Week 52
Change From Baseline in Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and Week 52
This is a three-item questionnaire assessing the impact of PS on the participant's sleep, daily activities, and quality of life (QoL) over the past 7 days. All questions have response options ranging from 0 to 4, not at all to extremely. A reduction from baseline represents a decrease in symptoms.
Time frame: Baseline, Week 24 and Week 52
Trough Apraglutide Plasma Concentration (Ctrough)
Time frame: Pre-dose on Weeks 2, 4, 12, 24, 32, 40, 48, and 52
Mean Plasma Citrulline Level
Time frame: Baseline and Weeks 2, 4, 12, 24, 32, 40, 48, and 52
| Milestone | Apraglutide SC Injections, Once Weekly |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
A TEAE was any unfavorable and unintended sign, symptom, or disease temporally associated with apraglutide, whether or not related, that occurred or worsened after the dose of apraglutide. A serious TEAE was defined as any TEAE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. Clinically significant changes from baseline in clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADAs), and urine analysis were reported as adverse events. Adverse events of special interest (AESI) included injection site reaction, gastrointestinal obstruction, gallbladder, biliary, and pancreatic disease, fluid overload, colorectal polyps, malignancies.
| Participants | Apraglutide SC Injections, Once Weekly |
|---|---|
| At least one TEAE | 9 |
| At least one treatment-related TEAE | 5 |
| At least one TESAE | 3 |
| At least one treatment-related TESAE | 1 |
| At least one treatment-emergent AESI | 3 |
| At least one TEAE leading to dose interruption | 1 |
| At least one TEAE leading to permanent dose discontinuation | 0 |
Applicable to Protocol V3.0 implemented in France (classed as secondary endpoint in Protocol V4.0 \[implemented in Belgium\]). The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
| kJ/day | Apraglutide SC Injections, Once Weekly |
|---|---|
| Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48 | 1133.963 ± 1399.8793 |
The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.
| percentage change in PS volume | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 4 | -0.73 ± 2.709 |
| Week 24 | -39.99 ± 22.588 |
| Week 52 | -52.44 ± 29.192 |
The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.
| mL | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 24 | -3510.000 ± 1893.7859 |
| Week 52 | -4701.778 ± 2389.9652 |
Participants were considered to have a reduction of at least one day per week of PS from Baseline (incl. extra fluids) if the number of days with PS from weekly PS diary data recorded for the corresponding analysis timepoint was smaller compared to the number of days with PS from weekly PS diary data for Baseline.
| Participants | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 24 | 5 |
| Week 52 | 7 |
Clinical response was defined as a 20% reduction of PS volume from Baseline. The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis.
| Participants | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 24 | 7 |
| Week 52 | 9 |
Enteral autonomy was defined as a participant not receiving PS for hydration or parenteral nutrition (PN) for calories. Participants may have still receive minimal fluid to maintain patency of the central line or for specific elemental/micro-nutrient needs (e.g., \<100 mL fluid for administration of magnesium).
| Participants | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 24 | 0 |
| Week 52 | 2 |
PN was defined as PS that includes protein, carbohydrate, fat, vitamins, and/or trace elements.
| kcal | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 24 | -2763.889 ± 1830.8065 |
| Week 52 | -3510.111 ± 1927.2066 |
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
| percentage change | Apraglutide SC Injections, Once Weekly |
|---|---|
| Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48 | 29.23 ± 36.898 |
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
| kJ/day | Apraglutide SC Injections, Once Weekly |
|---|---|
| Fat - Week 4 | 247.281 ± 661.1866 |
| Fat - Week 48 | 406.741 ± 776.4802 |
| Carbohydrate - Week 4 | 272.881 ± 675.1125 |
| Carbohydrate - Week 48 | 877.011 ± 945.2279 |
| Protein - Week 4 | 176.178 ± 280.0788 |
| Protein - Week 48 | 194.400 ± 285.2597 |
Based on average daily urine volume data derived as per balance period calculations.
| mL/day | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 4 | 246.889 ± 343.3609 |
| Week 48 | -178.556 ± 299.5613 |
The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
| kJ/day | Apraglutide SC Injections, Once Weekly |
|---|---|
| Absolute Change in Absorption of Energy Over MB Periods From Baseline at Week 4 | 494.259 ± 1355.5857 |
Since urinary electrolytes data were measured over the 72-hour MB period, the average of all available results were used for analyses for each MB parameter at a given analysis time point.
| cmol/L | Apraglutide SC Injections, Once Weekly |
|---|---|
| Calcium - Week 4 | 0.1444 ± 1.09818 |
| Calcium - Week 48 | -0.5532 ± 2.28264 |
| Magnesium - Week 4 | -0.258 ± 0.8370 |
| Magnesium - Week 48 | -2.306 ± 3.1400 |
| Sodium - Week 4 | 31.668 ± 24.1946 |
| Sodium - Week 48 | 17.097 ± 50.1676 |
| Potassium - Week 4 | 2.047 ± 16.8154 |
| Potassium - Week 48 | -8.012 ± 13.5798 |
| Urea - Week 4 | 7.693 ± 59.2590 |
| Urea - Week 48 | -89.649 ± 77.9786 |
| Creatinine - Week 4 | 0.198 ± 1.0071 |
| Creatinine - Week 48 | -0.011 ± 1.3283 |
The PSQI is a patient-reported questionnaire used to measure the quality and patterns of sleep, over the past month. The PSQI has seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Minimum Score = 0 (better); Maximum Score = 21 (worse). A negative change from baseline represents an reduction in symptoms.
| score on a scale | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 24 | -1.89 ± 2.667 |
| Week 52 | -1.56 ± 1.509 |
PGIC v2.0 is a single-item questionnaire using a 5-point verbal rating scale, to assess overall change in the participants status after taking the study drug. Response options range from 2= very much better to -2= very much worse.
| Participants | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 24 — 2 (Much Better) | 6 |
| Week 24 — 1 (A Little Better) | 2 |
| Week 52 — 2 (Much Better) | 8 |
| Week 52 — 1 (A Little Better) | 1 |
This form is a single-item questionnaire assessing the participant's satisfaction with the trial medication over the preceding 7 days. Response options range from -2 to 2, very dissatisfied to very satisfied.
| Participants | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 24 — 2 (Very Satisfied) | 5 |
| Week 24 — 1 (Satisfied) | 3 |
| Week 52 — 2 (Very Satisfied) | 3 |
| Week 52 — 1 (Satisfied) | 6 |
This is a single-item questionnaire assessing the participant's satisfaction with PS over the preceding 7 days. Response options range from -2 to 2, very dissatisfied to very satisfied. A reduction from baseline represents a decrease in satisfaction.
| score on a scale | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 24 | -0.20 ± 0.447 |
| Week 52 | 0.00 ± 0.000 |
This is a three-item questionnaire assessing the impact of PS on the participant's sleep, daily activities, and quality of life (QoL) over the past 7 days. All questions have response options ranging from 0 to 4, not at all to extremely. A reduction from baseline represents a decrease in symptoms.
| score on a scale | Apraglutide SC Injections, Once Weekly |
|---|---|
| Sleep Impact: Week 24 | -0.40 ± 1.517 |
| Sleep Impact: Week 52 | -0.50 ± 1.291 |
| Daily Activities Impact: Week 24 | -0.80 ± 1.643 |
| Daily Activities Impact: Week 52 | -1.00 ± 1.414 |
| QoL Impact: Week 24 | -1.40 ± 1.140 |
| QoL Impact: Week 52 | -1.25 ± 0.957 |
| ng/mL | Apraglutide SC Injections, Once Weekly |
|---|---|
| Week 2 | 1.928 ± 0.7058 |
| Week 4 | 1.217 ± 0.2902 |
| Week 12 | 1.934 ± 0.6665 |
| Week 24 | 2.863 ± 1.0668 |
| Week 32 | 1.739 ± 0.6805 |
| Week 40 | 2.386 ± 0.9587 |
| Week 48 | 3.810 ± 1.1031 |
| Week 52 | 2.678 ± 1.4039 |
| μmol/L | Apraglutide SC Injections, Once Weekly |
|---|---|
| Baseline | 11.571 ± 9.7091 |
| Week 2 | 13.516 ± 9.8136 |
| Week 4 | 15.531 ± 12.4055 |
| Week 12 | 14.860 ± 12.2165 |
| Week 24 | 14.810 ± 11.8877 |
| Week 32 | 14.994 ± 12.6880 |
| Week 40 | 17.860 ± 15.8020 |
| Week 48 | 16.638 ± 14.9346 |
| Week 52 | 14.714 ± 11.7896 |
Collected over Day 1 up to approximately 55 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Apraglutide SC Injections, Once Weekly | 0/9 (0%) | 3/9 (33.3%) | 9/9 (100%) |
| Event | Apraglutide SC Injections, Once Weekly |
|---|---|
| DiarrhoeaGastrointestinal disorders | 1/9 |
| Pancreatitis acuteGastrointestinal disorders | 1/9 |
| CholangitisHepatobiliary disorders | 1/9 |
| Campylobacter gastroenteritisInfections and infestations | 1/9 |
| Septic shockInfections and infestations | 1/9 |
| Device dislocationProduct Issues | 1/9 |
| Event | Apraglutide SC Injections, Once Weekly |
|---|---|
| VomitingGastrointestinal disorders | 5/9 |
| NasopharyngitisInfections and infestations | 5/9 |
| DiarrhoeaGastrointestinal disorders | 3/9 |
| Injection site erythemaGeneral disorders | 2/9 |
| Procedural vomitingInjury, poisoning and procedural complications | 2/9 |
| Procedural painInjury, poisoning and procedural complications | 2/9 |
| HeadacheNervous system disorders | 2/9 |
| Abdominal painGastrointestinal disorders | 2/9 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/9 |
| InfluenzaInfections and infestations | 2/9 |
All enrolled and treated participants.
| Age, Continuous(years) | Apraglutide SC Injections, Once Weekly |
|---|---|
| Mean | 46.8 ± 17.46 |
| Age, Customized(Participants) | Apraglutide SC Injections, Once Weekly |
|---|---|
| 18-64 years | 8 |
| 65-84 years | 1 |
| Sex: Female, Male(Participants) | Apraglutide SC Injections, Once Weekly |
|---|---|
| Female | 7 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Apraglutide SC Injections, Once Weekly |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Apraglutide SC Injections, Once Weekly |
|---|---|
| White | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2021 to primary completion in Jun 2023, 23 months.
Results were first posted in Jun 2025, 2 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Apraglutide