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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011003-23 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFT505 80mg | Experimental |
| |
| Matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFT505 80mg | Drug | Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral Glucose test Tolerance (OGTT) | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Volume oxygen maximal (VO2max) | 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. | 5 weeks |
| Respiratory parameters measured during the physical exercise test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémy Hanf, Development Director | GENFIT, France | Study Director |
| Eric BRUCKERT, Pr. | University Hospital of Paris 6, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site n°31 | Angers | 49000 | France | |||
| Site n°32 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23703580 | Derived | 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. | |
| 21816979 |
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| Placebo | Drug | Hard gelatin capsules, oral administration, 4 capsules per day before breakfast. |
|
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. |
| 5 weeks |
| Fasting Glycemia and Insulinemia | 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. | 5 weeks |
| HOMA index (Homeostasis Model Assessment) | 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. | 5 weeks |
| Lipids | 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). | 5 weeks |
| Angers |
| 49000 |
| France |
| Site n°36 | Angers | 49000 | France |
| Site n°37 | Angers | 49000 | France |
| Site n°34 | Angers | 49100 | France |
| Site n°35 | Angers | 49100 | France |
| Site n°39 | Angers | 49100 | France |
| Site n°17 | Briollay | 49125 | France |
| Site n°16 | Cholet | 49300 | France |
| Site n°19 | Cholet | 49300 | France |
| Site n°14 | Le Mesnil-en-Vallée | 49410 | France |
| Site n°10 | Mûrs-Erigné | 49610 | France |
| Site n°12 | Mûrs-Erigné | 49610 | France |
| Site n°2 | Nantes | 44093 | France |
| Site n°13 | Parçay-les-Pins | 49390 | France |
| Site n°1 | Paris | 75013 | France |
| Site n°15 | Segré | 49500 | France |
| Site n°11 | Thouars | 79100 | France |
| Site n°30 | Tiercé | 49125 | France |
| Site n°18 | Vihiers | 49310 | France |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C585906 | 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid |
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