A Pilot study to evaluate the Efficacy and Safety of GFT505 orally administered once daily (30 mg) for 28 days in atherogenic dyslipidaemic patients with abdominal obesity. A double blind, placebo-controlled and randomized study.

GENFIT0 sites30 target enrollmentAugust 28, 2007

Overview

No summary available.

Registry

who.int

Start Date

August 28, 2007

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Provide written informed consent prior to enrolment
•2\. Male or post\-menopausal female (defined as \>12 months since last menstrual period and with stable (at least 6 months prior to screening) and continuous Hormonal Replacement Therapy if any – surgical removal of ovaries can be considered as surgical menopause”)
•3\. Aged 18 to 75 years
•4\. Atherogenic dyslipidaemia inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise)\* \- \*(documented or highly probable at V1\)
•5\. Waist circumference \= 102 cm for men, \= 88 cm for women
•6\. Non\-hypertensive or patient taking antihypertensive medication maintained at a stable dose for 2 months at least prior to screening (and the stable dose can be maintained throughout the study)
•7\. Fasting TG \= 200 mg/dL and \= 500 mg/dL (2,28 mmol/L \= TG \= 5,65 mmol/L) at V2
•8\. Fasting HDL\-C \= 40 mg/dL (\= 1\.03 mmol/L) for men, HDL\-C \= 50 mg/dL (\= 1\.29 mmol/L) for women at V2
•9\. Fasting LDL\-C \< 190 mg/dL (\< 4\.91 mmol/L) at V2
•10\. Patient agrees to come to following visits and it is possible to schedule V4 and V5 inside the protocol specified range (14 days \+/\- 2 days between V3 and V4 ; 14 days \+/\- 2 days between V4 and V5\)

•1\. Body Mass Index (BMI) \= 35 kg/m²
•2\. Known clinical evidence of Coronary Artery Disease prior to or at screening
•3\. Blood Pressure \> 160 / 95 mmHg
•4\. Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 21 alcoholic beverages per week is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer
•5\. Type I or Type II diabetes mellitus
•6\. Known homozygous familial hypercholesterolaemia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
•7\. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B or C
•8\. Known history of malignant disease (excluding treated basal cell carcinoma)
•9\. Patients who have serious or unstable medical or psychological conditions which, in the opinion of the Investigator, would lead the patient to be non\-compliant or uncooperative during the study or would compromise the patient’s safety or successful participation in the study
•10\. Patients who have donated blood or blood products within the previous month prior to screening or who plan to donate blood or blood products at any time during the trial and in the 3 months following the end of the study