Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT07190794
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESCUE: Discontinuation of GLP-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent total body weight loss (TBWL) at 1 year from baseline', 'timeFrame': '12 months', 'description': 'The study will measure the percentage of total body weight loss for a period of one year from baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in body mass index (BMI)', 'timeFrame': '12 months', 'description': 'The study will measure change in BMI for a period of one year from baseline.'}, {'measure': 'Percentage of excess weight loss', 'timeFrame': '12 months', 'description': 'The study will measure the percentage of excess weight loss for a period of one year from baseline.'}, {'measure': 'Percentage of patients that achieved 5%, 10% and 15% total body weight loss', 'timeFrame': '12 months', 'description': 'The study will measure the percentage of patients that achieved 5%, 10% and 15% total body weight loss in the one year from baseline.'}, {'measure': 'Metabolic markers, if available', 'timeFrame': '12 months', 'description': 'Metabolic markers include changes from baseline in the following items:\n\n1. HbA1c\n2. Fasting blood glucose\n3. Total cholesterol\n4. LDL\n5. HDL\n6. Triglycerides\n7. Blood pressure (systolic and diastolic blood pressure)'}, {'measure': 'Visit compliance and impact to responder rate', 'timeFrame': '12 months', 'description': 'Responders are defined as \\>= 10% TBWL. This analysis will analyze if responder rate improves with higher visit compliance (number of completed interactions with a provider for weight loss management).'}, {'measure': 'Rate of procedure-related serious adverse events within 1-year post-ESG', 'timeFrame': '12 months', 'description': 'The study will examine the rate of procedure-related serious adverse events within 1-year post-ESG.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['GLP-1', 'ESG', 'OverStitch'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare weight loss outcomes and safety of ESG versus lifestyle modification in patients with obesity who discontinued GLP-1 therapy due to intolerance or suboptimal weight loss.', 'detailedDescription': 'This retrospective cohort study includes collection of data from medical records for consecutively treated patients undergoing treatment for weight loss following GLP-1 discontinuation. Weight loss treatment is either ESG with OverStitch™ OverStitch NXT™ or matched timeframe controls who participated in a lifestyle modification program for weight loss management.\n\nSubjects will be enrolled in a 2:1 ratio (ESG: Lifestyle modification)\n\nPatients are required to have the following visits for weight loss management:\n\n* Completed initial consultation visit (baseline) prior to initiation of weight management program with documented GLP-1 history and reason for discontinuation\n* Initiation of weight loss management between August 2021 and September 2024\n* A minimum of two weight loss management visits, defined as performed by the physician that is managing the weight loss program and/or an affiliated weight loss specialist, completed at 1, 3, 6, or 9 months from the initiation of weight loss management\n* Completed 1-year weight loss management visit (as defined above)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults over 18 years of age who were prescribed GLP-1 medication for weight loss and discontinued it due to intolerance of symptoms or suboptimal weight loss.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults (≥ 18 years)\n2. BMI ≥30 kg/m² and ≤ 50 kg/m2\n3. Discontinued GLP-1 therapy for weight loss (semaglutide and tirzepatide only) for intolerance or suboptimal weight loss (\\<5% TBWL after 3 months at maximally tolerated dose)\n4. Initiation of weight loss management between August 2021 and September 2024\n5. Completed 1-year follow-up for weight loss management (ESG and lifestyle modification or lifestyle modification alone) following initiation of weight loss treatment\n6. Completed at least two interim visits for weight loss management from 1, 3, 6, through 9 months following initiation of weight loss treatment\n\nExclusion Criteria:\n\n1. Missing data regarding GLP-1 treatment history, including weight before GLP-1 treatment and at discontinuation, and discontinuation reason\n2. History of GLP-1 medication for a reason other than weight management\n3. Had bariatric surgery or an endoscopic procedure for weight loss treatment other than ESG with OverStitch™ or OverStitch NXT™ within 1 year of starting weight loss management\n4. Had an additional endoscopic treatment performed prior to or at the time of the ESG procedure that could influence weight loss results\n5. Had another weight loss treatment during the 1-year follow-up reported during this study. Weight loss treatment includes but is not limited to appetite suppressants, anti-obesity medications, plastic surgery or body contouring procedures.\n6. Pregnancy during the 1 year following initiation of weight loss management'}, 'identificationModule': {'nctId': 'NCT07190794', 'briefTitle': 'RESCUE: Discontinuation of GLP-1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Evaluation of Endoscopic Sleeve Gastroplasty (ESG) as an Alternative Weight Loss Strategy for Patients With Obesity Discontinuing GLP-1 Receptor Agonists Due to Intolerance or Ineffectiveness: A Retrospective Study', 'orgStudyIdInfo': {'id': 'E7234'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESG Recipients', 'description': 'After discontinuing GLP-1 medication, this group elected to have an ESG procedure as a weight loss treatment.', 'interventionNames': ['Device: OverStitch™ or OverStitch NXT™']}, {'label': 'Lifestyle Modification', 'description': 'After discontinuing GLP-1 medication, this group elected to participate in a structured lifestyle modification program.', 'interventionNames': ['Behavioral: Lifestyle Modification']}], 'interventions': [{'name': 'OverStitch™ or OverStitch NXT™', 'type': 'DEVICE', 'description': "The OverStitch™ or OverStitch NXT™ Endoscopic Suturing System was used as part of each patient's ESG procedure within the routine clinical practice.", 'armGroupLabels': ['ESG Recipients']}, {'name': 'Lifestyle Modification', 'type': 'BEHAVIORAL', 'description': 'Patients participated in a lifestyle modification program for weight loss management.', 'armGroupLabels': ['Lifestyle Modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33179', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pichamol Jirapinyo, MD, MPH', 'role': 'CONTACT', 'email': 'pjirapinyo@bariendo.com', 'phone': '305-921-4219'}], 'facility': 'Bariendo', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michele Ryan', 'role': 'CONTACT', 'email': 'mryan@bwh.harvard.edu', 'phone': '617-732-5500'}], 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zim Warda Hasan', 'role': 'CONTACT', 'email': 'zh00027@mix.wvu.edu', 'phone': '364-203-1900'}], 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'centralContacts': [{'name': 'Katherine Stroud', 'role': 'CONTACT', 'email': 'katherine.stroud@bsci.com', 'phone': '617-233-5845'}, {'name': 'Pooja Goswamy', 'role': 'CONTACT', 'email': 'pooja.goswamy@bsci.com', 'phone': '508-683-4335'}], 'overallOfficials': [{'name': 'Pichamol Jirapinyo, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}