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

Phase 2

Completed

• Conditions: Atherogenic Dyslipidaemia; Abdominal Obesity
• Interventions: Drug: GFT505 80mg; Drug: Placebo

• Registration Number: NCT01271751
• Lead Sponsor: Genfit

Brief 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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-09
• Study Completion: 2009-11
• Status Verified: 2011-01
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Last Update Submitted: 2011-01-06
• Study First Posted: 2011-01-07
• Last Update Posted: 2011-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GFT505 80mg	GFT505 80mg	-
Matching placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Decrease in serum Triglycerides (TG) level	28 days	To evaluate the efficacy of GFT505 80mg in reducing serum TG compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
Increase in serum High Density Lipoprotein Cholesterol (HDL-C) level	28 days	To evaluate the efficacy of GFT505 80mg in increasing HDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)

Secondary Outcome Measures

Name	Time	Method
Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels	28 days	To evaluate the efficacy of GFT505 80mg in reducing LDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)
Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels	28 days	To evaluate the efficacy of GFT505 80mg in reducing non-HDL-C levels compared with placebo. Evaluation will be made during the selection period, then the first day prior any drug intake, 2 and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit)

Trial Locations

Locations (47)

Site n°26; 🇫🇷 Cholet, France

Site n°32; 🇫🇷 La Chapelle Sur Erdre, France

Site n°80; 🇫🇷 Angers, France

Site n°14; 🇫🇷 Cholet, France

Site n°91; 🇫🇷 Laval, France

Site n°82; 🇫🇷 Angers, France

Site n°35; 🇫🇷 le Temple de Bretagne, France

Site n°78; 🇫🇷 Angers, France

Site n°16; 🇫🇷 Beaucouze, France

Site n°79; 🇫🇷 Angers, France

Site n°21; 🇫🇷 Baune, France

Site n°45; 🇫🇷 Heric, France

Site n°18; 🇫🇷 Briollay, France

Site n°36; 🇫🇷 Aigrefeuille Sur Maine, France

Site n°42; 🇫🇷 Haute Goulaine, France

Site n°11; 🇫🇷 La Jubaudière, France

Site n°30; 🇫🇷 La Montagne, France

Site n°23; 🇫🇷 Le Mesnil en Vallée, France

Site n°12; 🇫🇷 Les Ponts de Ce, France

Site n°10; 🇫🇷 Murs-Erigné, France

Site n°33; 🇫🇷 Orvault, France

Site n°74; 🇫🇷 Montrevault, France

Site n°17; 🇫🇷 Montreuil Juigne, France

Site n°40; 🇫🇷 Nantes, France

Site n°19; 🇫🇷 Murs-Erigné, France

Site n°31; 🇫🇷 Nantes, France

Site n°41; 🇫🇷 Nort sur Erdre, France

Site n°37; 🇫🇷 Nantes, France

Site n°34; 🇫🇷 Nantes, France

Site n°1; 🇫🇷 Paris, France

Site n°38; 🇫🇷 St Etienne de Montluc, France

Site n°77; 🇫🇷 Tierce, France

Site n°39; 🇫🇷 Sautron, France

Site n°13; 🇫🇷 Segre, France

Site n°20; 🇫🇷 Vihiers, France

Site n°75; 🇫🇷 Tierce, France

Site n°64; 🇷🇴 Brasov, Romania

Site n°60; 🇷🇴 Bucharest, Romania

Site n°65; 🇷🇴 Craiova, Romania

Site n°52; 🇹🇳 Bab Sâadoun Tunis, Tunisia

Site n°53; 🇹🇳 Bab Sâadoun Tunis, Tunisia

Site n°62; 🇷🇴 Bucharest, Romania

Site n°51; 🇹🇳 Tunis, Tunisia

Site n°55; 🇹🇳 Tunis, Tunisia

Site n°50; 🇹🇳 Tunis, Tunisia

Site n°61; 🇷🇴 Bucharest, Romania

Site n°63; 🇷🇴 Bucharest, Romania