Trial | NCT01271751  Report issue

Title

Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity
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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    gft505 ...

  • Study Participants

    96
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.
Study Started
Jan 31
2009
Primary Completion
Sep 30
2009
Study Completion
Nov 30
2009
Last Update
Jan 07
2011
Estimate

Drug GFT505 80mg

hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast

Drug Placebo

hard gelatin capsules, oral administration, 4 capsules per day before breakfast

GFT505 80mg Experimental

Matching placebo Placebo Comparator

Criteria 

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.
No Results Posted