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.
- Conditions
- Atherogenic dyslipidaemic patients with abdominal obesityMedDRA version: 9.1Level: LLTClassification code 10059179Term: Abdominal obesityMedDRA version: 9.1Level: LLTClassification code 10058110Term: Dyslipidemia
- Registration Number
- EUCTR2007-004337-41-FR
- Lead Sponsor
- GENFIT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
11. The Patient is a female of childbearing potential, is pregnant or lactating
12. Any medication that may interfere with study medication absorption, distribution, metabolism or excretion or could lead to induction or inhibition of microsomial enzymes within 3 months prior to the screening day
13. Currently taking other investigational drugs or who have taken part in a clinical trial within the previous month prior to screening
14. Patient having already taken GFT505 during his/her participation in a previous clinical trial
15. Known intolerance or contra-indication to the list of excipients of GFT505 (Gelatin, Lactose, Glycerol, Titanium dioxide, Red Iron dioxide)
16. Patient not covered by Health Insurance System and / or not in compliance with the recommendations of National Law in force
17. Patient who cannot be contacted in case of emergency
18. Uncontrolled hypothyroidism defined as TSH > 2 x the upper limit of normal (ULN) at V2 (thyroid dysfunction controlled for at least 6 months prior to screening is permitted)
19. Significant renal disease, including nephritic syndrome, chronic renal failure and/or serum creatinine >180µmol/L at V2
20. Active liver disease or hepatic dysfunction as defined by elevations in liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyltransferase (GGT) and alkaline phosphatases (ALP)] > 2 x the upper limit of normal (ULN) at V2
21. Unexplained serum creatine kinase (CPK) > 3 x the upper limit of normal (ULN) at V2. Patients with a reason for CPK elevation may continue in screening and have the measurement repeated prior to randomization; a repeat CPK > 3 x ULN is exclusionary
22. Patient for whom the wash-out period of lipid-regulating drugs (fibrates, statins and other classes of lipid-regulating drugs) has not been respected or who has taken any other drug that is known to affect the lipid metabolism
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method