A Phase 2 interventional study of GFT505 80mg and Placebo in Atherogenic Dyslipidaemia and Abdominal Obesity, sponsored by Genfit. Completed at 47 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-01-07.
Sponsored by Genfit · Phase 2, Interventional, and Treatment
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.
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.
During 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.
283 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.
This study's enrollment of 96 is above the median of 58 across 223 interventional studies indexed under Obesity, Abdominal.
Browse Obesity, Abdominal studies →Genfit is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: GFT505 80mg
Drug: Placebo
hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
hard gelatin capsules, oral administration, 4 capsules per day before breakfast
Decrease in serum Triglycerides (TG) level
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)
Time frame: 28 days
Increase in serum High Density Lipoprotein Cholesterol (HDL-C) level
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)
Time frame: 28 days
Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels
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)
Time frame: 28 days
Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels
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)
Time frame: 28 days
The record gives a start of Jan 2009, a primary completion of Sep 2009 and a completion of Nov 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Elifibranor