Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT01271751
Status:
COMPLETED
Last Update Posted:
2011-01-07
First Post:
2011-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': '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': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-06', 'studyFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in serum Triglycerides (TG) level', 'timeFrame': '28 days', 'description': 'To evaluate the efficacy of GFT505 80mg in reducing serum TG compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)'}, {'measure': 'Increase in serum High Density Lipoprotein Cholesterol (HDL-C) level', 'timeFrame': '28 days', 'description': 'To evaluate the efficacy of GFT505 80mg in increasing HDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)'}], 'secondaryOutcomes': [{'measure': 'Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels', 'timeFrame': '28 days', 'description': 'To evaluate the efficacy of GFT505 80mg in reducing LDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)'}, {'measure': 'Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels', 'timeFrame': '28 days', 'description': 'To evaluate the efficacy of GFT505 80mg in reducing non-HDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atherogenic-dyslipidaemia', 'PPARs'], 'conditions': ['Atherogenic Dyslipidaemia', '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 in reducing serum Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.', 'detailedDescription': 'The study period per patient is 7 to 14 weeks: a screening period (1 to 8 weeks) will precede a 4-week double-blind treatment period and a 2-week follow-up period.\n\nDuring the screening period, patients will be asked to start or continue adequate diet and exercise and to stop their lipid-lowering medication (for not treatment-naïve patients). For patient taking any lipid-regulating medication, a minimum of 8-week wash-out from lipid-regulating therapies (fibrates, statins, …) is required.'}, '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 ≥102cm for male, ≥ 88cm for female.\n* Atherogenic dislipidaemia inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise).\n* 150≤ fasting TG ≤ 600 mg/dL (1.69 ≤ fasting TG ≤ 6.78 mmol/L) at V2.\n* Fasting HDL-C ≤ 40 mg/dL (≤ 1.03 mmol/L) for male, HDL-C ≤ 45 mg/dL (≤ 1.16 mmol/L) for female at V2.\n\nExclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 40 kg/m².\n* Blood Pressure \\> 160 / 95 mmHg.\n* Type I or type II Diabetes Mellitus.'}, 'identificationModule': {'nctId': 'NCT01271751', 'briefTitle': 'Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genfit'}, 'officialTitle': 'A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 28 Days in Atherogenic Dyslipidaemic Patients With Abdominal Obesity. A Double Blind, Placebo-controlled and Randomized Study.', 'orgStudyIdInfo': {'id': 'GFT505-208-3'}, 'secondaryIdInfos': [{'id': '2008-005779-86', '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': '44140', 'city': 'Aigrefeuille-sur-Maine', 'country': 'France', 'facility': 'Site n°36', 'geoPoint': {'lat': 47.08008, 'lon': -1.40419}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°78', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°79', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°80', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Site n°82', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '49140', 'city': 'Bauné', 'country': 'France', 'facility': 'Site n°21', 'geoPoint': {'lat': 47.49954, 'lon': -0.31906}}, {'zip': '49070', 'city': 'Beaucouzé', 'country': 'France', 'facility': 'Site n°16', 'geoPoint': {'lat': 47.47514, 'lon': -0.63219}}, {'zip': '49125', 'city': 'Briollay', 'country': 'France', 'facility': 'Site n°18', 'geoPoint': {'lat': 47.56446, 'lon': -0.50805}}, {'zip': '49300', 'city': 'Cholet', 'country': 'France', 'facility': 'Site n°14', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'zip': '49300', 'city': 'Cholet', 'country': 'France', 'facility': 'Site n°26', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'zip': '44115', 'city': 'Haute-Goulaine', 'country': 'France', 'facility': 'Site n°42', 'geoPoint': {'lat': 47.19904, 'lon': -1.43012}}, {'zip': '44810', 'city': 'Héric', 'country': 'France', 'facility': 'Site n°45', 'geoPoint': {'lat': 47.41299, 'lon': -1.65234}}, {'zip': '44240', 'city': 'La Chapelle-sur-Erdre', 'country': 'France', 'facility': 'Site n°32', 'geoPoint': {'lat': 47.29964, 'lon': -1.55239}}, {'zip': '49510', 'city': 'La Jubaudière', 'country': 'France', 'facility': 'Site n°11', 'geoPoint': {'lat': 47.17202, 'lon': -0.89215}}, {'zip': '44620', 'city': 'La Montagne', 'country': 'France', 'facility': 'Site n°30', 'geoPoint': {'lat': 47.18987, 'lon': -1.68395}}, {'zip': '53000', 'city': 'Laval', 'country': 'France', 'facility': 'Site n°91', 'geoPoint': {'lat': 48.07247, 'lon': -0.77019}}, {'zip': '49410', 'city': 'Le Mesnil-en-Vallée', 'country': 'France', 'facility': 'Site n°23', 'geoPoint': {'lat': 47.36551, 'lon': -0.93485}}, {'zip': '44360', 'city': 'Le Temple-de-Bretagne', 'country': 'France', 'facility': 'Site n°35', 'geoPoint': {'lat': 47.32868, 'lon': -1.79143}}, {'zip': '49130', 'city': 'Les Ponts-de-Cé', 'country': 'France', 'facility': 'Site n°12', 'geoPoint': {'lat': 47.42315, 'lon': -0.52477}}, {'zip': '49460', 'city': 'Montreuil-Juigné', 'country': 'France', 'facility': 'Site n°17', 'geoPoint': {'lat': 47.52829, 'lon': -0.61233}}, {'zip': '49110', 'city': 'Montrevault', 'country': 'France', 'facility': 'Site n°74', 'geoPoint': {'lat': 47.26145, 'lon': -1.04579}}, {'zip': '49610', 'city': 'Murs-Erigné', 'country': 'France', 'facility': 'Site n°10'}, {'zip': '49610', 'city': 'Murs-Erigné', 'country': 'France', 'facility': 'Site n°19'}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Site n°40', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44100', 'city': 'Nantes', 'country': 'France', 'facility': 'Site n°37', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44300', 'city': 'Nantes', 'country': 'France', 'facility': 'Site n°31', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44300', 'city': 'Nantes', 'country': 'France', 'facility': 'Site n°34', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44390', 'city': 'Nort-sur-Erdre', 'country': 'France', 'facility': 'Site n°41', 'geoPoint': {'lat': 47.4399, 'lon': -1.49909}}, {'zip': '44700', 'city': 'Orvault', 'country': 'France', 'facility': 'Site n°33', 'geoPoint': {'lat': 47.27117, 'lon': -1.62361}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Site n°1', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '44360', 'city': 'Saint-Étienne-de-Montluc', 'country': 'France', 'facility': 'Site n°38', 'geoPoint': {'lat': 47.27622, 'lon': -1.78013}}, {'zip': '44880', 'city': 'Sautron', 'country': 'France', 'facility': 'Site n°39', 'geoPoint': {'lat': 47.26345, 'lon': -1.67222}}, {'zip': '49500', 'city': 'Segré', 'country': 'France', 'facility': 'Site n°13', 'geoPoint': {'lat': 47.68672, 'lon': -0.87268}}, {'zip': '49125', 'city': 'Tiercé', 'country': 'France', 'facility': 'Site n°75', 'geoPoint': {'lat': 47.6157, 'lon': -0.46787}}, {'zip': '49125', 'city': 'Tiercé', 'country': 'France', 'facility': 'Site n°77', 'geoPoint': {'lat': 47.6157, 'lon': -0.46787}}, {'zip': '49310', 'city': 'Vihiers', 'country': 'France', 'facility': 'Site n°20', 'geoPoint': {'lat': 47.1458, 'lon': -0.5346}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Site n°64', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'zip': '010243', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site n°61', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': 'Sector 2', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site n°60', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': 'Sector 2', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site n°63', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site n°62', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Site n°65', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '1029', 'city': 'Bab Sâadoun Tunis', 'country': 'Tunisia', 'facility': 'Site n°52'}, {'zip': '1029', 'city': 'Bab Sâadoun Tunis', 'country': 'Tunisia', 'facility': 'Site n°53'}, {'zip': '1007', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Site n°50', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'zip': '1007', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Site n°51', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'zip': '1089', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Site n°55', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], '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'}}}}