Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.
NCT ID: NCT01275469
Last Updated: 2011-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2009-06-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GFT505 80mg
GFT505 80mg
Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.
Matching placebo
Placebo
Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.
Interventions
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GFT505 80mg
Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.
Placebo
Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.
Eligibility Criteria
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Inclusion Criteria
* Waist circumference ≥94cm for male, ≥ 80cm for female.
* 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.
* 2-hour glycaemia at OGTT (2hr after a 75g oral glucose load) ≥140 mg/dL (7.8 mmol/l).
Exclusion Criteria
* Blood Pressure \> 160 / 95 mmHg.
* Known Type I or type II Diabetes Mellitus.
* Glycated haemoglobin (HbA1c) \>7%.
* A fasting TG \> 400mg/dl and a LDL-C \> 220mg/dl.
18 Years
75 Years
ALL
No
Sponsors
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Genfit
INDUSTRY
Responsible Party
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GENFIT
Principal Investigators
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Rémy Hanf, Development Director
Role: STUDY_DIRECTOR
GENFIT, France
Eric BRUCKERT, Pr.
Role: STUDY_CHAIR
University Hospital of Paris 6, France
Locations
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Site n°31
Angers, , France
Site n°32
Angers, , France
Site n°36
Angers, , France
Site n°37
Angers, , France
Site n°34
Angers, , France
Site n°35
Angers, , France
Site n°39
Angers, , France
Site n°17
Briollay, , France
Site n°16
Cholet, , France
Site n°19
Cholet, , France
Site n°14
Le Mesnil-en-Vallée, , France
Site n°10
Mûrs-Erigné, , France
Site n°12
Mûrs-Erigné, , France
Site n°2
Nantes, , France
Site n°13
Parçay-les-Pins, , France
Site n°1
Paris, , France
Site n°15
Segré, , France
Site n°11
Thouars, , France
Site n°30
Tiercé, , France
Site n°18
Vihiers, , France
Countries
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References
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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.
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.
Other Identifiers
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2009-011003-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GFT505-209-4
Identifier Type: -
Identifier Source: org_study_id
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