Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT07228403
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-22
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Evaluation of Glepaglutide in Treatment of SBS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment emergent adverse events (TEAEs)', 'timeFrame': 'From baseline to the safety follow-up visit (A maximum of 25 months)'}], 'secondaryOutcomes': [{'measure': 'Change in prescribed weekly parenteral support (PS) volume', 'timeFrame': 'From baseline to Month 24 (End of Trial)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malabsorption Syndromes', 'Intestinal Diseases', 'Gastrointestinal Diseases', 'Digestive System Diseases', 'Postoperative Complications', 'Pathologic Processes', 'Pathological Conditions, Signs and Symptoms', 'Short Bowel Syndrome'], 'conditions': ['Short Bowel Syndrome (SBS)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.', 'detailedDescription': 'This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has provided signed informed consent and agrees to comply with protocol requirements.\n* Is being\n\n 1. Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or\n 2. Actively treated in the EASE SBS 3 trial.\n\nExclusion Criteria:\n\n* Has a condition, disease, or circumstance that, in the opinion of the investigator, would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial.\n* Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed.\n* Had major protocol deviation(s) (as determined by the sponsor) in the EASE SBS 2 or EASE SBS 3 trial that would affect the conduct of the present trial.\n* Has permanently discontinued the trial treatment because of an AE, assessed as related to the trial drug in the EASE SBS 2 or EASE SBS 3 trial. (Note: AEs are treatment-emergent unless otherwise specified.)\n* If female, is of childbearing potential, pregnant, breastfeeding, intends to become pregnant, or is not using contraceptive methods. Refer to Section 10.2.2 for the definition of contraception.\n* Has a known or suspected hypersensitivity to glepaglutide or related products.\n* Has committed to an institution by virtue of an order issued by the judicial or administrative authorities.\n* Is an employee of the sponsor or investigator or otherwise dependent on them.'}, 'identificationModule': {'nctId': 'NCT07228403', 'acronym': 'EASE SBS 6', 'briefTitle': 'Efficacy and Safety Evaluation of Glepaglutide in Treatment of SBS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zealand Pharma'}, 'officialTitle': 'A 104-week, Multicenter, Open-label, Single-arm, Phase 3 Extension Trial Investigating the Long-term Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Rolling Over From the EASE SBS 2 or 3 Trials', 'orgStudyIdInfo': {'id': 'ZP1848-25009'}, 'secondaryIdInfos': [{'id': '2025-520775-81-00', 'type': 'CTIS'}, {'id': 'U1111-1317-8307', 'type': 'OTHER', 'domain': 'UT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label Glepaglutide', 'interventionNames': ['Drug: Glepaglutide 10 mg']}], 'interventions': [{'name': 'Glepaglutide 10 mg', 'type': 'DRUG', 'otherNames': ['ZP1848'], 'description': 'Administered twice weekly by subcutaneous injection for a maximum of 24 months', 'armGroupLabels': ['Open-label Glepaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - PPDS', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Lied Transplant Center at Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '44195-0001', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic-9500 Euclid Ave', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37212-2700', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center-Tennesse-1211 21st Ave S', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven - PPDS', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LHSC - University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '92118', 'city': 'Clichy', 'state': 'Hauts-de-Seine', 'country': 'France', 'facility': 'AP-HP - Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '18057', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Universitätsmedizin Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '32-050', 'city': 'Skawina', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Szpital Skawina sp. z o.o. im. Stanley Dudricka', 'geoPoint': {'lat': 49.97524, 'lon': 19.82869}}, {'zip': '00-416', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego CMKP', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '90-531', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Wojewódzki Szpital Specjalistycznyo im. M. Pirogowa w Lodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': 'NW10 7NS', 'city': 'Ealing', 'country': 'United Kingdom', 'facility': "St Mark's Hospital (Central Middlesex Hospital)", 'geoPoint': {'lat': 51.51216, 'lon': -0.30204}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}