Abdominal Obesity, Atherogenic Dyslipidaemia
Conditions
Keywords
Atherogenic-dyslipidaemia, PPARs
Brief summary
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.
Detailed description
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.
Interventions
DRUGGFT505 80mg
hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
DRUGPlacebo
hard gelatin capsules, oral administration, 4 capsules per day before breakfast
Sponsors
Genfit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or post-menopausal female. * Waist circumference ≥102cm for male, ≥ 88cm for female. * Atherogenic dislipidaemia inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise). * 150≤ fasting TG ≤ 600 mg/dL (1.69 ≤ fasting TG ≤ 6.78 mmol/L) at V2. * 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.
Exclusion criteria
* Body Mass Index (BMI) ≥ 40 kg/m². * Blood Pressure \> 160 / 95 mmHg. * Type I or type II Diabetes Mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in serum Triglycerides (TG) level | 28 days | 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) |
| Increase in serum High Density Lipoprotein Cholesterol (HDL-C) level | 28 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels | 28 days | 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) |
| Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels | 28 days | 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) |
Countries
France, Romania, Tunisia
Outcome results
None listed