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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005129-99 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apraglutide | Experimental | All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apraglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4, Week 24, and Week 52 |
| Absolute Change From Baseline in Actual Weekly PS Volume at Weeks 24 and 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Masior | VectivBio AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium | |||
| Beaujon Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41903849 | Derived | Ekhlas D, Verbiest A, Stas M, De Meyere L, Vandermeulen G, Toth J, Geboers K, Timmermans L, Verspecht C, Wauters L, Vermeersch P, Jeppesen PB, Verbeke K, Joly F, Derrien M, Raes J, Vanuytsel T. Early ecological changes in intestinal microbiota with the long-acting GLP-2 analog apraglutide in short bowel syndrome. Clin Nutr ESPEN. 2026 Jun;73:103138. doi: 10.1016/j.clnesp.2026.103138. Epub 2026 Mar 26. | |
| 39461299 |
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Of the 10 participants with SBS-IF and CIC enrolled, 9 participants were treated and analyzed. The participant who enrolled but was not treated was not included in any study analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apraglutide SC Injections, Once Weekly | All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled and treated participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Apraglutide SC Injections, Once Weekly | All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | No | Day 1 up to approximately 55 weeks |
|
Day 1 up to approximately 55 weeks
The safety analysis set included all participants exposed to trial medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apraglutide SC Injections, Once Weekly | All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information Desk | VectivBio AG | 617.621.7722 | ClinicalTrialEnquiries@ironwoodpharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2022 | May 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2022 | May 11, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| D000090124 | Intestinal Failure |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000710330 | apraglutide |
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|
The sum of daily PS volume (including extra fluids) from weekly PS diary data recorded for the corresponding analysis timepoint was used for analysis. |
| 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Week 24 and Week 52 |
| Trough Apraglutide Plasma Concentration (Ctrough) | Pre-dose on Weeks 2, 4, 12, 24, 32, 40, 48, and 52 |
| Mean Plasma Citrulline Level | Baseline and Weeks 2, 4, 12, 24, 32, 40, 48, and 52 |
| Clichy |
| 92110 |
| France |
| Derived |
| Verbiest A, Hvistendahl MK, Bolognani F, Li C, Youssef NN, Huh S, Menys A, Bhatnagar G, Vanslembrouck R, Peeters R, Sartoris R, Vermeersch P, Wauters L, Verbeke K, Jeppesen PB, Joly F, Vanuytsel T. Efficacy and safety of apraglutide in short bowel syndrome with intestinal failure and colon-in-continuity: A multicenter, open-label, metabolic balance study. Clin Nutr. 2024 Dec;43(12):158-166. doi: 10.1016/j.clnu.2024.10.011. Epub 2024 Oct 16. |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks. |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | kJ/day | Baseline and Week 48 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | percentage change in PS volume | Baseline, Week 4, Week 24, and Week 52 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | mL | Baseline, Week 24 and Week 52 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | No | Baseline, Week 24 and Week 52 |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | No | Baseline, Week 24 and 52 |
|
|
|
| Secondary | 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). | 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. | Posted | Count of Participants | Participants | No | Weeks 24 and 52 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | kcal | Baseline, Week 24 and Week 52 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | percentage change | Baseline and Week 48 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | kJ/day | Baseline, Week 4 and Week 48 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | mL/day | Baseline, Week 4 and Week 48 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | kJ/day | Baseline and Week 4 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | cmol/L | Baseline, Week 4 and Week 48 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 and Week 52 |
|
|
|
|
| Secondary | 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. | 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 with an assessment at given time point. | Posted | Count of Participants | Participants | No | Baseline, Week 24 and Week 52 |
|
|
|
| Secondary | 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. | 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 with an assessment at given time point. | Posted | Count of Participants | Participants | No | Week 24 and Week 52 |
|
|
|
| Secondary | 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. | 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. Partcipants with an assessment at given time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 and Week 52 |
|
|
|
| Secondary | 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. | 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 with an assessment at given time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 and Week 52 |
|
|
|
| Secondary | Trough Apraglutide Plasma Concentration (Ctrough) | The safety analysis set included all participants exposed to trial medication. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose on Weeks 2, 4, 12, 24, 32, 40, 48, and 52 |
|
|
|
| Secondary | Mean Plasma Citrulline Level | The safety analysis set included all participants exposed to trial medication. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | μmol/L | Baseline and Weeks 2, 4, 12, 24, 32, 40, 48, and 52 |
|
|
|
| 0 |
| 9 |
| 3 |
| 9 |
| 9 |
| 9 |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA 24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Complication associated with device | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Catheter site irritation | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Vascular access site pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Vascular device infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Magnesium deficiency | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Superiority |
| Superiority |
| Title | Measurements |
|---|---|
|
| Carbohydrate - Week 48 |
|
| Protein - Week 4 |
|
| Protein - Week 48 |
|
| 0.155 |
| Superiority |
| Carbohydrate absorption at Week 4 | paired t-test | 0.260 | Superiority |
| Carbohydrate absorption at Week 48 | paired t-test | 0.024 | Superiority |
| Protein absorption at Week 4 | paired t-test | 0.096 | Superiority |
| Protein absorption at Week 48 | paired t-test | 0.075 | Superiority |
| Superiority |
| Title | Measurements |
|---|---|
|
| Magnesium - Week 48 |
|
| Sodium - Week 4 |
|
| Sodium - Week 48 |
|
| Potassium - Week 4 |
|
| Potassium - Week 48 |
|
| Urea - Week 4 |
|
| Urea - Week 48 |
|
| Creatinine - Week 4 |
|
| Creatinine - Week 48 |
|
Calcium, Week 48
| paired t-test |
| 0.488 |
| Median Difference (Final Values) |
| -0.1040 |
| 2-Sided |
| 95 |
| -2.7442 |
| 0.8896 |
Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. |
| Superiority |
| Magnesium, Week 4 | paired t-test | 0.382 | Median Difference (Final Values) | -0.219 | 2-Sided | 95 | -0.896 | 0.313 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Magnesium, Week 48 | paired t-test | 0.059 | Median Difference (Final Values) | -1.566 | 2-Sided | 95 | -5.279 | -0.165 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Sodium, Week 4 | paired t-test | 0.004 | Median Difference (Final Values) | 33.116 | 2-Sided | 95 | 5.510 | 51.861 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Sodium, Week 48 | paired t-test | 0.337 | Median Difference (Final Values) | 20.727 | 2-Sided | 95 | -27.758 | 55.828 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Potassium, Week 4 | paired t-test | 0.724 | Median Difference (Final Values) | 1.618 | 2-Sided | 95 | -11.870 | 14.931 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Potassium, Week 48 | paired t-test | 0.115 | Median Difference (Final Values) | -9.190 | 2-Sided | 95 | -18.880 | 3.737 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Urea, Week 4 | paired t-test | 0.707 | Median Difference (Final Values) | 12.297 | 2-Sided | 95 | -39.551 | 52.617 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Urea, Week 48 | paired t-test | 0.009 | Mean Difference (Final Values) | -91.487 | 2-Sided | 95 | -159.956 | -20.068 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Creatinine, Week 4 | paired t-test | 0.572 | Median Difference (Final Values) | 0.281 | 2-Sided | 95 | -0.649 | 0.960 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Creatinine, Week 48 | paired t-test | 0.981 | Median Difference (Final Values) | -0.136 | 2-Sided | 95 | -1.060 | 1.073 | Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline. | Superiority |
| Superiority |
| Week 52 |
|
|
| Week 52 |
|
|
|
|
| Daily Activities Impact: Week 24 |
|
|
| Daily Activities Impact: Week 52 |
|
|
| QoL Impact: Week 24 |
|
|
| QoL Impact: Week 52 |
|
|
| Title | Measurements |
|---|---|
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 32 |
|
|
| Week 40 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| Title | Measurements |
|---|---|
|
| Week 4 |
|
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| Week 12 |
|
|
| Week 24 |
|
|
| Week 32 |
|
|
| Week 40 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|