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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Genfit
- Enrollment
- 96
- Locations
- 47
- Primary Endpoint
- Decrease in serum Triglycerides (TG) level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 V
- •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.
Arms & Interventions
GFT505 80mg
Intervention: GFT505 80mg (Drug)
Matching placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Decrease in serum Triglycerides (TG) level
Time Frame: 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
Time Frame: 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 Outcomes
- Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels(28 days)
- Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels(28 days)