Trial · NCT04964986
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
NCT04964986, Phase 2, Completed, VectivBio AG; results first posted 2025-06-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC). Trials, record NCT04964986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04964986
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
- NCT number
- NCT04964986
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- VectivBio AG
- Conditions
- Short Bowel Syndrome
- Interventions
- Apraglutide
- First posted
- 2021-07-16
- Last updated
- 2025-06-18
- Other registries' IDs
- eudract:2020-005129-99
- Results first posted
- 2025-06-18
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | Day 1 up to approximately 55 weeks | 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. |
| Primary | Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48 | Baseline and 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. |
| Secondary | Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52 | Baseline, Week 4, Week 24, and Week 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. |
| Secondary | Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52 | Baseline, Week 24 and Week 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. |
| Secondary | Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52 | Baseline, Week 24 and Week 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. |
| Secondary | Number of Participants Considered Clinical Responders at Weeks 24 and 52 | Baseline, Week 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. |
| Secondary | Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52 | 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). |
| Secondary | Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52 | Baseline, Week 24 and Week 52 | PN was defined as PS that includes protein, carbohydrate, fat, vitamins, and/or trace elements. |
| Secondary | Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48 | Baseline and 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. |
| Secondary | Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48 | Baseline, Week 4 and 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | Day 1 up to approximately 55 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48 | Baseline and Week 48 | The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point. | kJ/day | MEAN |
| SECONDARY | Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52 | Baseline, Week 4, Week 24, and Week 52 | The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point. | percentage change in PS volume | MEAN |
| SECONDARY | Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52 | Baseline, Week 24 and Week 52 | The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point. | mL | MEAN |
| SECONDARY | Number of Participants Who Achieved a Reduction of at Least 1 Day Per Week of PS From Baseline at Weeks 24 and 52 | Baseline, Week 24 and Week 52 | The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Considered Clinical Responders at Weeks 24 and 52 | Baseline, Week 24 and 52 | The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Enteral Autonomy at Weeks 24 and 52 | Weeks 24 and 52 | The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Change in Total Energy in PN From Baseline at Weeks 24 and 52 | Baseline, Week 24 and Week 52 | The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point. | kcal | MEAN |
| SECONDARY | Relative Change in Absorption of Energy Over MB Periods From Baseline at Week 48 | Baseline and Week 48 | The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point. | percentage change | MEAN |
| SECONDARY | Absolute Change in Absorption of Macronutrients Over MB Periods From Baseline at Weeks 4 and 48 | Baseline, Week 4 and Week 48 | The full analysis set included all participants who received at least one dose of trial treatment and contributed at least one valid post-baseline efficacy point. | kJ/day | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | Apraglutide SC Injections, Once Weekly | At least one TEAE | 9 | Participants | |
| Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | Apraglutide SC Injections, Once Weekly | At least one treatment-related TEAE | 5 | Participants | |
| Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | Apraglutide SC Injections, Once Weekly | At least one TESAE | 3 | Participants | |
| Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | Apraglutide SC Injections, Once Weekly | At least one treatment-related TESAE | 1 | Participants | |
| Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | Apraglutide SC Injections, Once Weekly | At least one treatment-emergent AESI | 3 | Participants | |
| Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | Apraglutide SC Injections, Once Weekly | At least one TEAE leading to dose interruption | 1 | Participants | |
| Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | Apraglutide SC Injections, Once Weekly | At least one TEAE leading to permanent dose discontinuation | 0 | Participants | |
| Absolute Change in Absorption of Energy Over Metabolic Balance (MB) Periods From Baseline at Week 48 | Apraglutide SC Injections, Once Weekly | 1133.963 | Standard Deviation 1399.8793 | kJ/day | |
| Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52 | Apraglutide SC Injections, Once Weekly | Week 4 | -0.73 | Standard Deviation 2.709 | percentage change in PS volume |
| Relative Change From Baseline in Actual Weekly Parenteral Support (PS) Volume at Weeks 4, 24, and 52 | Apraglutide SC Injections, Once Weekly | Week 24 | -39.99 | Standard Deviation 22.588 | percentage change in PS volume |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Apraglutide SC Injections, Once Weekly | 9 | |
| Overall Study | COMPLETED | Apraglutide SC Injections, Once Weekly | 9 | |
| Overall Study | NOT COMPLETED | Apraglutide SC Injections, Once Weekly | 0 |
Source ClinicalTrials.gov
Adverse events59
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Haematoma | Vascular disorders | Apraglutide SC Injections, Once Weekly | 1 | 9 | |
| other | Asthenia | General disorders | Apraglutide SC Injections, Once Weekly | 1 | 9 | |
| other | Complication associated with device | General disorders | Apraglutide SC Injections, Once Weekly | 1 | 9 | |
| other | Catheter site irritation | General disorders | Apraglutide SC Injections, Once Weekly | 1 | 9 | |
| other | Injection site erythema | General disorders | Apraglutide SC Injections, Once Weekly | 2 | 9 | |
| other | Injection site pruritus | General disorders | Apraglutide SC Injections, Once Weekly | 1 | 9 | |
| other | Fatigue | General disorders | Apraglutide SC Injections, Once Weekly | 1 | 9 | |
| other | Injection site haematoma | General disorders | Apraglutide SC Injections, Once Weekly | 1 | 9 | |
| other | Injection site pain | General disorders | Apraglutide SC Injections, Once Weekly | 1 | 9 | |
| other | Dysphonia | Respiratory, thoracic and mediastinal disorders | Apraglutide SC Injections, Once Weekly | 1 | 9 |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apraglutide SC Injections, Once Weekly | 0 | 9 |
| Total, other adverse events | Apraglutide SC Injections, Once Weekly | 9 | 9 |
| Total, serious adverse events | Apraglutide SC Injections, Once Weekly | 3 | 9 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04964986
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