Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity - Full Text View

Purpose

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.

Condition	Intervention	Phase
Atherogenic Dyslipidaemia Abdominal Obesity	Drug: GFT505 80mg Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Obesity

U.S. FDA Resources

Further study details as provided by Genfit:

Primary Outcome Measures:

Decrease in serum Triglycerides (TG) level [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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:

Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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)

Enrollment:	96
Study Start Date:	January 2009
Study Completion Date:	November 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GFT505 80mg	Drug: GFT505 80mg hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
Placebo Comparator: Matching placebo	Drug: Placebo hard gelatin capsules, oral administration, 4 capsules per day before breakfast

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271751

Show 47 Study Locations

Sponsors and Collaborators

Genfit

Investigators

Study Director:	Rémy Hanf, Development Director	GENFIT, France
Study Chair:	Eric BRUCKERT, Pr.	University Hospital of Paris 6, France

More Information

No publications provided by Genfit

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cariou B, Zaïr Y, Staels B, Bruckert E. Effects of the new dual PPAR ?/? agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. Diabetes Care. 2011 Sep;34(9):2008-14. Epub 2011 Aug 4.

Responsible Party:	Product Development Department, Genfit
ClinicalTrials.gov Identifier:	NCT01271751 History of Changes
Other Study ID Numbers:	GFT505-208-3, 2008-005779-86
Study First Received:	January 6, 2011
Last Updated:	January 6, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Romania: Ethics Committee Romania: National Medicines Agency Tunisia: Ministry of Public Health

Keywords provided by Genfit:

Atherogenic-dyslipidaemia
PPARs

Additional relevant MeSH terms:

Obesity
Dyslipidemias
Obesity, Abdominal
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013