Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-30 @ 12:32 PM
Study NCT ID:
NCT03593668
Status:
UNKNOWN
Last Update Posted:
2019-05-24
First Post:
2018-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect and Safety of Benaglutide or Metformin in Patients With Simple Obesity Who Have Inadequate Weight Control
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in body weight', 'timeFrame': 'Change from Baseline after 12 weeks treatment', 'description': 'Changes in body weight from baseline were observed in patients with simple obesity after 12 weeks of treatment intervention.'}], 'secondaryOutcomes': [{'measure': 'Changes in body mass index (BMI) of subjects', 'timeFrame': 'Change from Baseline after 12 weeks treatment', 'description': 'All 30 subjects of each group would be evaluted by changes in body mass index (BMI) after 12 weeks treatment'}, {'measure': 'Changes in Body Fat Levels', 'timeFrame': 'Change from Baseline after 12 weeks treatment', 'description': 'Changes in Body Fat Levels from Baseline: Body Composition Analysis'}, {'measure': 'Changes in blood lipid levels', 'timeFrame': 'Change from Baseline after 12 weeks treatment', 'description': 'The changes in blood lipid levels such as cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein will be measured at the beginning and the end.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metformin', 'Benaglutide'], 'conditions': ['Obesity; Drug']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.', 'detailedDescription': 'This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.\n\nScreening will be made to select eligible participants before intervention. Patients were randomly assigned to one of two groups(metformin or benaglutide) for therapies for 12 weeks including a two-week dose adjustment period and a 10-week dose stabilization period. Lifestyle interventions will be maintained during the treatment period. Subjects are followed up every 4 weeks for examinations.At the end of the study, data will be collected and analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n(1)20 years old≤70 years old; (2) simple obesity, gender is not limited; (3) 28.0≤BMI≤37.5kg/m2; (4) Before the screening period, the body weight was controlled by lifestyle interventions (diet and exercise) for at least 3 months, and weight was decreased by \\<5% from baseline; (5) Agree to sign the informed consent form;\n\nExclusion Criteria:\n\n1. Accurately diagnosed as having type 1 or type 2 diabetes according to the WHO 1999 diagnostic criteria;\n2. Use weight loss drugs within 3 months before screening;\n3. Metformin was used within the first 3 months of screening;\n4. Malignant tumors (excluding basal cell or squamous cell carcinoma treated) within 5 years before enrollment\n5. Alanine aminotransferase or aspartate aminotransferase \\> 3 times the upper limit of normal or total serum bilirubin (TB) \\>34.2 μmol/L (\\>2 mg/dL)\n6. Patients with moderate/severe renal impairment or end-stage renal disease (eGFR \\< 60 mL/min/1.73 m2); male subjects with serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL Serum Cr in female subjects was ≥124 μmol/L (\\>1.40 mg/dL);\n7. Severe heart, lung, nervous, mental and infectious diseases;\n8. Pregnancy, lactation and recent pregnancy plans;\n9. Alternate or chronic systemic corticosteroid therapy, defined as treatment with any dose of systemic corticosteroids within 3 months of enrollment visit V1 \\> 4 weeks\n10. History of alcohol abuse, history of abuse of active drugs (opioids, analgesics, etc.) within 6 months before enrollment;\n11. Give any other test drug within 30 days before enrollment or within 5 half-lives of other test drugs;\n12. Patients with past history or family history of medullitary thyroid cancer (MTC) and patients with type 2 multiple endocrine tumor syndrome (MEN2);\n13. Inability to tolerate benalutide, metformin;\n14. Any influence of the investigator's judgment on enrollment."}, 'identificationModule': {'nctId': 'NCT03593668', 'briefTitle': 'Effect and Safety of Benaglutide or Metformin in Patients With Simple Obesity Who Have Inadequate Weight Control', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Effect and Safety of Benaglutide or Metformin in Patients With Simple Obesity Who Have Inadequate Weight Control :A Randomized, Open, Controlled and Single-site Clinical Trail', 'orgStudyIdInfo': {'id': 'MET2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Metformin Hydrochloride Tablet 500mg po by month,three times a day for 12 weeks', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Benaglutide', 'description': 'Benaglutide Injection 0.2mg, iH,po, three times a day for 3 12 weeks', 'interventionNames': ['Drug: Benaglutide']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage', 'Metformin Hydrochloride Tablet'], 'description': '2-week dose adjustment period（0-2weeks）\\[before meals\\] 0-2d： - ;250mg，po; -. 3-4d： - ;250mg，po; 250mg，po. 5-6d： 250mg，po; 250mg，po; 250mg，po. 7-9d: 250mg，po; 500mg，po; 250mg，po. 10-11d: 250mg，po; 500mg，po; 500mg，po. 12-14d: 500mg，po; 500mg，po; 500mg，po.\n\n10-week dose stabilization period（3-12weeks） Metformin Hydrochloride Tablet 500mg tid po.', 'armGroupLabels': ['Metformin']}, {'name': 'Benaglutide', 'type': 'DRUG', 'otherNames': ['Benaglutide Injection'], 'description': '2-week dose adjustment period（0-2weeks） \\[before meals\\] 0-2d: -; 0.1mg，iH; -; 3-4d: -; 0.1mg，iH; 0.1mg，iH; 5-6d: 0.1mg，iH; 0.1mg，iH; 0.1mg，iH; 7-9d: 0.1mg，iH; 0.2mg，iH; 0.1mg，iH; 10-11d: 0.1mg，iH; 0.2mg，iH; 0.2mg，iH; 12-14d: 0.2mg，iH; 0.2mg，iH; 0.2mg，iH.\n\n10-week dose stabilization period（3-12weeks） Benaglutide Injection 0.2mg，100ul，tid，iH', 'armGroupLabels': ['Benaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dalong Zhu, MD,PhD', 'role': 'CONTACT', 'email': 'zhudldr@gmail.com', 'phone': '86-25-83-105302'}, {'name': 'Yan Bi, MD,PhD', 'role': 'CONTACT', 'email': 'biyan@nju.edu.cn', 'phone': '86-25-83-105302'}, {'name': 'Dalong Zhu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yan Bi, MD，PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Dalong Zhu, MD,PhD', 'role': 'CONTACT', 'email': 'zhudldr@gmail.com', 'phone': '86-25-83-105302'}, {'name': 'Yan Bi, MD,PhD', 'role': 'CONTACT', 'email': 'biyan@nju.edu.cn', 'phone': '86-25-83-105302'}], 'overallOfficials': [{'name': 'Dalong Zhu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the Affiliated Drum Tower Hospital of Nanjing University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Dalong Zhu', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}