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

Launched by GENFIT · Jan 6, 2011

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.