Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT01275469
Status:
COMPLETED
Last Update Posted:
2011-01-12
First Post:
2011-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585906', 'term': '2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-11', 'studyFirstSubmitDate': '2011-01-10', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Glucose test Tolerance (OGTT)', 'timeFrame': '4 weeks', 'description': 'To evaluate the change in plasma Glucose 2hr following oral glucose load from baseline to end point. Evaluation will be made during the selection period, prior any drug intake, and 4 weeks (28-34 days) after the first treatment intake.'}], 'secondaryOutcomes': [{'measure': 'Volume oxygen maximal (VO2max)', 'timeFrame': '5 weeks', 'description': 'To evaluate the efficacy of GFT505 80mg compared with placebo in improving the VO2max at physical exercise test. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.'}, {'measure': 'Respiratory parameters measured during the physical exercise test', 'timeFrame': '5 weeks', 'description': 'To describe the changes on others parameters measured during the physical exercise test : Volume carbon dioxide (VCO2), Respiratory quotient (RQ), Lactate concentration. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.'}, {'measure': 'Fasting Glycemia and Insulinemia', 'timeFrame': '5 weeks', 'description': 'To describe the changes of fasting glycaemia and insulinemia in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.'}, {'measure': 'HOMA index (Homeostasis Model Assessment)', 'timeFrame': '5 weeks', 'description': 'To describe the changes of HOMA index in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.'}, {'measure': 'Lipids', 'timeFrame': '5 weeks', 'description': 'To describe the changes in Triglycerides (TG), High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C) and non High Density Lipoprotein Cholesterol (non-HDL-C) levels in the two groups. Evaluation will be made the first day prior any drug intake, then 2-3, and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Impaired Glucose tolerance', 'OGTT', 'PPARs'], 'conditions': ['Impaired Glucose Tolerance', 'Abdominal Obesity']}, 'referencesModule': {'references': [{'pmid': '23703580', 'type': 'DERIVED', 'citation': 'Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.'}, {'pmid': '21816979', 'type': 'DERIVED', 'citation': 'Cariou B, Zair Y, Staels B, Bruckert E. Effects of the new dual PPAR alpha/delta agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. Diabetes Care. 2011 Sep;34(9):2008-14. doi: 10.2337/dc11-0093. Epub 2011 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days.', 'detailedDescription': 'The study period is 13 weeks maximum per patient : A screening period (1 to 6-weeks) will precede a 5-week double-blind treatment period and a 2-week follow-up period. The duration of the screening period will depend on the necessity to introduce a wash-out for lipid-lowering drugs : 4-week wash-out from statins and other lipid regulating drugs and 6-week wash-out from fibrates. During the screening period, patients will be asked to start or continue adequate diet and exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or post-menopausal female.\n* Waist circumference ≥94cm for male, ≥ 80cm for female.\n* Fasting Plasma Glucose (FPG) between 110 and 126 mg/dl (between 6.1 and 7.0 mmol/l) within 6 months prior to the screening visit.\n* 2-hour glycaemia at OGTT (2hr after a 75g oral glucose load) ≥140 mg/dL (7.8 mmol/l).\n\nExclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 40 kg/m².\n* Blood Pressure \\> 160 / 95 mmHg.\n* Known Type I or type II Diabetes Mellitus.\n* Glycated haemoglobin (HbA1c) \\>7%.\n* A fasting TG \\> 400mg/dl and a LDL-C \\> 220mg/dl.'}, 'identificationModule': {'nctId': 'NCT01275469', 'briefTitle': 'Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genfit'}, 'officialTitle': 'A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.', 'orgStudyIdInfo': {'id': 'GFT505-209-4'}, 'secondaryIdInfos': [{'id': '2009-011003-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GFT505 80mg', 'interventionNames': ['Drug: GFT505 80mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GFT505 80mg', 'type': 'DRUG', 'description': 'Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.', 'armGroupLabels': ['GFT505 80mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.', 'armGroupLabels': ['Matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°31', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°32', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°36', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°37', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°34', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°35', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°39', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49125', 'city': 'Briollay', 'country': 'France', 'facility': 'Site n°17', 'geoPoint': {'lat': 47.56446, 'lon': -0.50805}}, {'zip': '49300', 'city': 'Cholet', 'country': 'France', 'facility': 'Site n°16', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'zip': '49300', 'city': 'Cholet', 'country': 'France', 'facility': 'Site n°19', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'zip': '49410', 'city': 'Le Mesnil-en-Vallée', 'country': 'France', 'facility': 'Site n°14', 'geoPoint': {'lat': 47.36551, 'lon': -0.93485}}, {'zip': '49610', 'city': 'Mûrs-Erigné', 'country': 'France', 'facility': 'Site n°10', 'geoPoint': {'lat': 47.39592, 'lon': -0.55293}}, {'zip': '49610', 'city': 'Mûrs-Erigné', 'country': 'France', 'facility': 'Site n°12', 'geoPoint': {'lat': 47.39592, 'lon': -0.55293}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Site n°2', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '49390', 'city': 'Parçay-les-Pins', 'country': 'France', 'facility': 'Site n°13', 'geoPoint': {'lat': 47.43668, 'lon': 0.16312}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Site n°1', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '49500', 'city': 'Segré', 'country': 'France', 'facility': 'Site n°15', 'geoPoint': {'lat': 47.68672, 'lon': -0.87268}}, {'zip': '79100', 'city': 'Thouars', 'country': 'France', 'facility': 'Site n°11', 'geoPoint': {'lat': 46.9815, 'lon': -0.21175}}, {'zip': '49125', 'city': 'Tiercé', 'country': 'France', 'facility': 'Site n°30', 'geoPoint': {'lat': 47.6157, 'lon': -0.46787}}, {'zip': '49310', 'city': 'Vihiers', 'country': 'France', 'facility': 'Site n°18', 'geoPoint': {'lat': 47.1458, 'lon': -0.5346}}], 'overallOfficials': [{'name': 'Rémy Hanf, Development Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GENFIT, France'}, {'name': 'Eric BRUCKERT, Pr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Paris 6, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genfit', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Product Development Department', 'oldOrganization': 'GENFIT'}}}}