Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 12:25 AM
Study NCT ID:
NCT07163650
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-01', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in %TWL from baseline to endpoint', 'timeFrame': '24 weeks from enrollment', 'description': 'Percentage decrease in total body weight in patients after intervention'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with different %TWL levels', 'timeFrame': '24 weeks from enrollment', 'description': 'Percentage of patients with varying proportions of weight loss from baseline after intervention'}, {'measure': 'Proportion of patients with normal weight and overweight', 'timeFrame': '24 weeks from enrollment', 'description': 'Percentage of patients with normal weight and overweight from baseline after intervention'}, {'measure': 'Changes in metabolic parameters', 'timeFrame': '24 weeks from enrollment', 'description': 'Changes in Biochemical Indicators, Glycated Hemoglobin (HbA1c), Insulin Resistance Indices, Nutritional Indicators, Body Composition, and Fatty Liver-Related Indices Compared with Baseline.'}, {'measure': 'Remission Status of Obesity-Related Diseases', 'timeFrame': '24 weeks from enrollment', 'description': 'Remission of Diabetes Mellitus, Hypertension, Fatty Liver Disease, Hyperlipidemia, Hyperuricemia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'BMI', 'GLP-1 receptor agonist', 'Efsubaglutide Alfa', 'Metabolic surgery'], 'conditions': ['Obesity', 'Weight Loss', 'GLP-1 Receptor Agonist', 'Metabolic Surgery']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to evaluate the weight-loss efficacy and safety of efsubaglutide alfa in patients who remain obese 6 months after metabolic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '6 months after metabolic surgery; 18 years ≤ age ≤ 55 years; Body Mass Index (BMI) ≥ 28 kg/m\\^2'}, 'identificationModule': {'nctId': 'NCT07163650', 'briefTitle': 'Randomized Controlled Trial Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Efsubaglutide Alfa in Patients Remaining Obese 6 Months After Metabolic Surgery', 'orgStudyIdInfo': {'id': '2025-0631-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efsubaglutide Alfa group', 'description': 'Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 24 weeks.', 'interventionNames': ['Drug: Efsubaglutide Alfa Injection', 'Behavioral: Diet and exercise guidelines']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'Receive guidance on diet and exercise throughout the program, without the use of drugs.', 'interventionNames': ['Behavioral: Diet and exercise guidelines']}], 'interventions': [{'name': 'Efsubaglutide Alfa Injection', 'type': 'DRUG', 'description': 'Efsubaglutide Alfa was injected daily in the morning before meals Subcutaneous injection at a dose of 1 mg/week in the first two weeks, increased to 3 mg/week in week 3, increased to 6 mg/week in week 5, up to 9 mg/2 week in week 13.', 'armGroupLabels': ['Efsubaglutide Alfa group']}, {'name': 'Diet and exercise guidelines', 'type': 'BEHAVIORAL', 'description': 'Participants followed a science-based diet and exercise program intervention.', 'armGroupLabels': ['Efsubaglutide Alfa group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhaoqun Chu', 'role': 'CONTACT', 'email': 'kejiaochu-2001@163.com', 'phone': '+86-25-83106666'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'wenhuan Feng', 'role': 'CONTACT', 'email': 'fengwh501@163.com', 'phone': '+86-25-83106666'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No participant data are available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}