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The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.
Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients with short bowel syndrome (SBS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glepaglutide SC injections twice weekly | Experimental | Intervention: Glepaglutide |
|
| Glepaglutide SC injections once weekly and placebo once weekly | Experimental | Intervention: Glepaglutide |
|
| Placebo SC injections twice weekly | Placebo Comparator | Intervention: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glepaglutide | Drug | Glucagon-Like Peptide-2 (GLP-2) analog |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weekly Parenteral Support (PS) Volume | Change in weekly PS volume from baseline to Week 24. Baseline actual weekly PS volume was defined as the actual PS volume derived from a valid 7-day period prior to visit 1 (Day 1), i.e. during the stabilization phase. The actual weekly PS volume at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 was derived as the actual weekly PS volume received during the valid 7-day period prior to the visit. The source for the derivation was the PS volumes recorded by the patients in the eDiary. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response in PS Volume | Clinical response, defined as at least 20% reduction in actual weekly PS volume from baseline to both Weeks 20 and 24. | 20 and 24 weeks |
| Days Off PS | Achieving 1 or more days per week off PS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Zealand Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| University of Chicago Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39708985 | Derived | Jeppesen PB, Vanuytsel T, Subramanian S, Joly F, Wanten G, Lamprecht G, Kunecki M, Rahman F, Nielsen TSS, Berner-Hansen M, Pape UF, Mercer DF. Glepaglutide, a Long-Acting Glucagon-like Peptide-2 Analogue, Reduces Parenteral Support in Patients With Short Bowel Syndrome: A Phase 3 Randomized Controlled Trial. Gastroenterology. 2025 Apr;168(4):701-713.e6. doi: 10.1053/j.gastro.2024.11.023. Epub 2024 Dec 19. |
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Patients were diagnosed with SBS and required PS at least 3 days/week. They were willing to adhere to an individual pre-defined drinking menu during 48 h measurement periods and maintain a stable weight.
The drinking menu and the PS volume and content were adjusted during an optimization phase following by a stabilization phase.
This trial was conducted in (number of sites that randomized patients in parenthesis) Belgium (1), Denmark (2), France (2), Germany (5), the Netherlands (1), Poland (3), Canada (3), the US (7), and the UK (5).
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| ID | Title | Description |
|---|---|---|
| FG000 | Glepaglutide SC Injections Twice Weekly | Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog |
| FG001 | Glepaglutide SC Injections Once Weekly and Placebo Once Weekly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 27, 2022 | Aug 2, 2024 |
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|
| Placebo | Drug | Placebo for glepaglutide |
|
| 24 weeks |
| Clinical Response in PS Volume | Reduction of at least 20 percent in PS volume from baseline to both 12 and 24 weeks. | 12 and 24 weeks |
| Weaned Off PS | Reduction in weekly PS volume of 100 percent (weaned off) | 24 weeks |
| Energy Content | Change in weekly energy content of PS from baseline | 24 weeks |
| Days on PS | Change in number of days on PS per week from baseline | 24 weeks |
| Change in PS Volume Per Week | Achieving reduction of at least 40 percent in PS volume from baseline to both 20 and 24 weeks | 20 and 24 weeks |
| Patient Global Impression of Change Scale (PGIC) | Patient Global Impression of Change scale (PGIC) improvement at Weeks 4, 12, 20, and 24 PGIC improvement was defined as responding "Very Much Improved" or "Much Improved" on a 7-point Likert Scale. Improvement between each glepaglutide treatment regimen compared to placebo was tested by week, using the CMH test adjusted for the stratification factor. Improvement between each glepaglutide treatment regimen versus placebo was tested using collapsed categories of Improvement, No Change, and Worsening, where Improvement is defined as a response of "Very Much Improved" or "Much Improved" or "Minimally Improved", and No Change is defined as the response of "No Change", and Worsening is defined as a response of "Minimally Worse" or "Much Worse" or "Very Much Worse". Improvement using collapsed categories between each glepaglutide treatment regimen compared to placebo was tested by week using a Mantel-Haenszel chi-squared test for ordered categories. | 24 weeks |
| Safety - Adverse Events | Incidence and type of Adverse Events over an average of 28 weeks (24 weeks treatment + 4 weeks follow up) | 28 weeks |
| Number of Patients With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) | Number of patients with clinically significant changes in ECG will be reported. Monitored ECG parameters included heart rate (beats/min), PR interval (ms), PR interval Aggregate (ms), QRS duration aggregate (ms), QT interval aggregate (ms), QTcF interval aggregate (ms), and RR interval (ms), as well as the overall interpretation of each subject's ECG recorded as Normal, Abnormal Not Clinically Significant, or Abnormal Clinically Significant. | 28 weeks |
| Safety - Changes in Blood Pressure From Baseline | Changes in blood pressure are reported at Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 The data collected data are of seated diastolic and systolic blood pressure (mmHg). During treatment phase visits, vital signs were collected before investigational product injection. | Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| Safety - Changes in Body Temperature From Baseline | Changes in body temperature are reported The body temperature (ºC or ºF) was measured according to the site's usual procedure. During treatment phase visits, vital signs were collected before investigational product injection. | 28 weeks |
| Immunogenicity - Occurrence of Anti-drug Antibodies | Occurrence of antibodies against glepaglutide The occurrence of glepaglutide-binding antibodies (ADA), M2 binding antibodies (M2 BAb), glepaglutide neutralizing antibodies (NAb) and GLP-2 cross-reacting antibodies (GLP-2 CR) was tested. | 28 weeks |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Mayo Clinic College of Medicine | Rochester | Minnesota | 55905 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-3285 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University Medical Center, Nashville | Nashville | Tennessee | 68198-3285 | United States |
| UZ Leuven | Leuven | Belgium |
| The Royal Alexandra Hospital | Edmonton | Canada |
| Western University | London | N6A 4V2 | Canada |
| University Health Network - Toronto General Hospital | Toronto | Canada |
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Hôpital Beaujon | Clichy | France |
| Centre Hospitalier Lyon-Sud | Pierre-Bénite | France |
| Charité - Universitätsmedizin Berlin | Berlin | Germany |
| Universitätsklinikum Bonn | Bonn | Germany |
| Universitätsklinikum Frankfurt - Med. Klinik I | Frankfurt | Germany |
| Asklepios Kliniken Hamburg GmbH | Hamburg | Germany |
| Universitätsmedizin Rostock | Rostock | Germany |
| UMC Radboud Nijmegen | Nijmegen | Netherlands |
| Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi | Lodz | Poland |
| Solumed | Poznan | Poland |
| Szpital Skawina sp. z o.o. im. Stanley Dudricka | Skawina | Poland |
| St Mark's Hospital | Harrow | United Kingdom |
| UCLH Foundation NHS Trust | London | United Kingdom |
| Salford Royal NHS Foundation Trust | Manchester | United Kingdom |
| University of East Anglia | Norwich | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | United Kingdom |
Intervention: Glepaglutide
glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog
Placebo: Placebo for glepaglutide
| FG002 | Placebo SC Injections Twice Weekly | Intervention: Placebo Placebo: Placebo for glepaglutide |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Glepaglutide SC Injections Twice Weekly | Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog |
| BG001 | Glepaglutide SC Injections Once Weekly and Placebo Once Weekly | Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide |
| BG002 | Placebo SC Injections Twice Weekly | Intervention: Placebo Placebo: Placebo for glepaglutide |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Change in Weekly Parenteral Support (PS) Volume | Change in weekly PS volume from baseline to Week 24. Baseline actual weekly PS volume was defined as the actual PS volume derived from a valid 7-day period prior to visit 1 (Day 1), i.e. during the stabilization phase. The actual weekly PS volume at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 was derived as the actual weekly PS volume received during the valid 7-day period prior to the visit. The source for the derivation was the PS volumes recorded by the patients in the eDiary. | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of trial drug (glepaglutide or placebo). All efficacy analyses were based on the FAS. Patients were included in the analyses as randomized. | Posted | Least Squares Mean | 95% Confidence Interval | L/week | 24 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response in PS Volume | Clinical response, defined as at least 20% reduction in actual weekly PS volume from baseline to both Weeks 20 and 24. | Posted | Count of Participants | Participants | 20 and 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Days Off PS | Achieving 1 or more days per week off PS | Posted | Count of Participants | Participants | 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response in PS Volume | Reduction of at least 20 percent in PS volume from baseline to both 12 and 24 weeks. | Posted | Count of Participants | Participants | 12 and 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weaned Off PS | Reduction in weekly PS volume of 100 percent (weaned off) | Posted | Count of Participants | Participants | 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Energy Content | Change in weekly energy content of PS from baseline | Posted | Median | Full Range | kJ/week | 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Days on PS | Change in number of days on PS per week from baseline | Posted | Median | Full Range | days/week | 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in PS Volume Per Week | Achieving reduction of at least 40 percent in PS volume from baseline to both 20 and 24 weeks | Posted | Count of Participants | Participants | 20 and 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change Scale (PGIC) | Patient Global Impression of Change scale (PGIC) improvement at Weeks 4, 12, 20, and 24 PGIC improvement was defined as responding "Very Much Improved" or "Much Improved" on a 7-point Likert Scale. Improvement between each glepaglutide treatment regimen compared to placebo was tested by week, using the CMH test adjusted for the stratification factor. Improvement between each glepaglutide treatment regimen versus placebo was tested using collapsed categories of Improvement, No Change, and Worsening, where Improvement is defined as a response of "Very Much Improved" or "Much Improved" or "Minimally Improved", and No Change is defined as the response of "No Change", and Worsening is defined as a response of "Minimally Worse" or "Much Worse" or "Very Much Worse". Improvement using collapsed categories between each glepaglutide treatment regimen compared to placebo was tested by week using a Mantel-Haenszel chi-squared test for ordered categories. | Posted | Number | participants | 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety - Adverse Events | Incidence and type of Adverse Events over an average of 28 weeks (24 weeks treatment + 4 weeks follow up) | Posted | Count of Participants | Participants | 28 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) | Number of patients with clinically significant changes in ECG will be reported. Monitored ECG parameters included heart rate (beats/min), PR interval (ms), PR interval Aggregate (ms), QRS duration aggregate (ms), QT interval aggregate (ms), QTcF interval aggregate (ms), and RR interval (ms), as well as the overall interpretation of each subject's ECG recorded as Normal, Abnormal Not Clinically Significant, or Abnormal Clinically Significant. | Posted | Count of Participants | Participants | 28 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety - Changes in Blood Pressure From Baseline | Changes in blood pressure are reported at Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 The data collected data are of seated diastolic and systolic blood pressure (mmHg). During treatment phase visits, vital signs were collected before investigational product injection. | At certain visits those data are missing for some patients. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety - Changes in Body Temperature From Baseline | Changes in body temperature are reported The body temperature (ºC or ºF) was measured according to the site's usual procedure. During treatment phase visits, vital signs were collected before investigational product injection. | At certain visits those data are missing for some patients. | Posted | Least Squares Mean | 95% Confidence Interval | degree C | 28 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity - Occurrence of Anti-drug Antibodies | Occurrence of antibodies against glepaglutide The occurrence of glepaglutide-binding antibodies (ADA), M2 binding antibodies (M2 BAb), glepaglutide neutralizing antibodies (NAb) and GLP-2 cross-reacting antibodies (GLP-2 CR) was tested. | Posted | Count of Participants | Participants | 28 weeks |
|
|
All AEs, whether serious or non-serious, were to be reported from the time a signed and dated Informed Consent Form (ICF) was obtained until the end of the post-treatment follow-up period on average 28 weeks.
Due to the long half-life of glepaglutide, all AEs with an onset after the first dose of glepaglutide were treated as 'treatment-emergent', including AEs with an onset during a treatment interruption.
For the 'Stoma complications' and related preferred terms, the denominators used in the calculation of % are based on patients with small intestine stoma (Glepa 10 mg TW: N=17; Glepa 10 mg OW: N=20; Placebo: N=21).
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 | Glepaglutide SC Injections Twice Weekly | Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog | 0 | 35 | 9 | 35 | 30 | 35 |
| EG001 | Glepaglutide SC Injections Once Weekly and Placebo Once Weekly | Intervention: Glepaglutide glepaglutide: Glucagon-Like Peptide-2 (GLP-2) analog Placebo: Placebo for glepaglutide | 0 | 35 | 10 | 35 | 31 | 35 |
| EG002 | Placebo SC Injections Twice Weekly | Intervention: Placebo Placebo: Placebo for glepaglutide | 0 | 36 | 7 | 36 | 25 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stoma site haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Catheter site necrosis | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA 24.1 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 24.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Stoma site oedema | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Stoma complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Stomal hernia | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Stoma site irritation | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Stoma site haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Stoma site reaction | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrointestinal bacterial overgrowth | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of clinical operations | Zealand Pharma A/S | +45 8877 3600 | info@zealandpharma.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2022 | Aug 2, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Netherlands |
|
| Belgium |
|
| United States |
|
| Denmark |
|
| Poland |
|
| United Kingdom |
|
| France |
|
| Germany |
|
| Difference to Placebo |
| -0.91 |
| 2-Sided |
| 95 |
| -2.52 |
| 0.71 |
| Superiority |
|
|
|
|
|
|
|
|
|
|
| Placebo SC Injections Twice Weekly |
Intervention: Placebo Placebo: Placebo for glepaglutide |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
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