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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014