NCT01271751

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherogenic Dyslipidaemia
• Abdominal Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-09-01
• Completion: 2009-11-01
• First posted: 2011-01-07
• Last updated: 2011-01-07

Locations

47 sites across 3 countries: France, Romania, Tunisia