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

This study has been completed.
Sponsor:
Information provided by:
Genfit
ClinicalTrials.gov Identifier:
NCT01271751
First received: January 6, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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:


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):
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 April 23, 2014