Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-25 @ 1:10 AM
Study NCT ID:
NCT00494767
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2006-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2007-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-04', 'studyFirstSubmitDate': '2006-10-31', 'studyFirstSubmitQcDate': '2007-06-28', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies.', 'timeFrame': 'Measurements at week 8 will be compared to measurements from Day -1'}], 'secondaryOutcomes': [{'measure': 'Safety (caloric losses body weight, body composition, weight and hip circumference.)', 'timeFrame': 'throughout study (Days 1-56)'}, {'measure': 'Leptin levels in serum', 'timeFrame': 'at several points during study'}, {'measure': 'Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax)', 'timeFrame': 'Day 42'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['body composition', 'obesity', '4C model', 'hunger', 'weight loss'], 'conditions': ['Diabetes Mellitus, Type 2', 'Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/KGW108201?search=study&search_terms=KGW108201#rs', 'label': 'Results for study KGW108201 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'The drugs GSK189075 and GW869682 result in increased caloric losses. This study is investigating how if taken over 8 weeks that affects weight loss, food intake and the composition of the body. The body composition (fat,water, lean mass) is determined using a new investigational MR technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* BMI of 30 - 40kg/m\n* Females may be included if they are surgically sterile or post-menopausal\n\nExclusion criteria:\n\n* Change in body weight \\>4% in the last 3 months\n* History of eating disorders\n* had bariatric surgical intervention for obesity\n* have type I or II diabetes\n* Thyroid disorder not under control\n* Renal or hepatobiliary disease\n* Excessive alcohol consumption\n* Use of drugs of abuse\n* donated of blood in the last 3 months'}, 'identificationModule': {'nctId': 'NCT00494767', 'briefTitle': 'Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Exploratory Study to Evaluate Weight Loss, Body Composition Changes, Food Intake and Urine Glucose Excretion in Healthy Obese Subjects Over 8 Weeks of Dosing With GSK189075, GW869682 Versus Placebo', 'orgStudyIdInfo': {'id': 'KGW108201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GW869682 1000 mg thrice daily (TID)', 'description': 'Subjects will be randomized to receive GW869682 1000 mg TID', 'interventionNames': ['Drug: GW869682', 'Drug: GSK189075', 'Drug: GSK189075-Placebo', 'Drug: GW869682-Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GSK189075 250 mg TID', 'description': 'Subjects will be randomized to receive GSK189075 250 mg TID', 'interventionNames': ['Drug: GW869682', 'Drug: GSK189075', 'Drug: GSK189075-Placebo', 'Drug: GW869682-Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'GW869682-Placebo TID', 'description': 'Subjects will be randomized to receive Placebo matching GW869682 for TID', 'interventionNames': ['Drug: GW869682', 'Drug: GSK189075', 'Drug: GSK189075-Placebo', 'Drug: GW869682-Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'GSK189075-Placebo TID', 'description': 'Subjects will be randomized to receive Placebo matching GSK189075 for TID', 'interventionNames': ['Drug: GW869682', 'Drug: GSK189075', 'Drug: GSK189075-Placebo', 'Drug: GW869682-Placebo']}], 'interventions': [{'name': 'GW869682', 'type': 'DRUG', 'description': 'GW869682 tablet with a dose strength of 250 mg will be available for subjects', 'armGroupLabels': ['GSK189075 250 mg TID', 'GSK189075-Placebo TID', 'GW869682 1000 mg thrice daily (TID)', 'GW869682-Placebo TID']}, {'name': 'GSK189075', 'type': 'DRUG', 'otherNames': ['GW869682'], 'description': 'GSK189075 tablet with a dose strength of 250 mg will be available for subjects', 'armGroupLabels': ['GSK189075 250 mg TID', 'GSK189075-Placebo TID', 'GW869682 1000 mg thrice daily (TID)', 'GW869682-Placebo TID']}, {'name': 'GSK189075-Placebo', 'type': 'DRUG', 'description': 'Placebo tablets to match GSK189075 250 mg will be available for subjects', 'armGroupLabels': ['GSK189075 250 mg TID', 'GSK189075-Placebo TID', 'GW869682 1000 mg thrice daily (TID)', 'GW869682-Placebo TID']}, {'name': 'GW869682-Placebo', 'type': 'DRUG', 'description': 'Placebo tablets to match GW869682 250 mg will be available for subjects', 'armGroupLabels': ['GSK189075 250 mg TID', 'GSK189075-Placebo TID', 'GW869682 1000 mg thrice daily (TID)', 'GW869682-Placebo TID']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 2GG', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}