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

January 6, 2011 updated by: Genfit

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aigrefeuille Sur Maine, France, 44140
        • Site n°36
      • Angers, France, 49000
        • Site n°78
      • Angers, France, 49000
        • Site n°79
      • Angers, France, 49000
        • Site n°80
      • Angers, France, 49000
        • Site n°82
      • Baune, France, 49140
        • Site n°21
      • Beaucouze, France, 49070
        • Site n°16
      • Briollay, France, 49125
        • Site n°18
      • Cholet, France, 49300
        • Site n°14
      • Cholet, France, 49300
        • Site n°26
      • Haute Goulaine, France, 44115
        • Site n°42
      • Heric, France, 44810
        • Site n°45
      • La Chapelle Sur Erdre, France, 44240
        • Site n°32
      • La Jubaudière, France, 49510
        • Site n°11
      • La Montagne, France, 44620
        • Site n°30
      • Laval, France, 53000
        • Site n°91
      • Le Mesnil en Vallée, France, 49410
        • Site n°23
      • Les Ponts de Ce, France, 49130
        • Site n°12
      • Montreuil Juigne, France, 49460
        • Site n°17
      • Montrevault, France, 49110
        • Site n°74
      • Murs-Erigné, France, 49610
        • Site n°10
      • Murs-Erigné, France, 49610
        • Site n°19
      • Nantes, France, 44000
        • Site n°40
      • Nantes, France, 44100
        • Site n°37
      • Nantes, France, 44300
        • Site n°31
      • Nantes, France, 44300
        • Site n°34
      • Nort sur Erdre, France, 44390
        • Site n°41
      • Orvault, France, 44700
        • Site n°33
      • Paris, France, 75013
        • Site n°1
      • Sautron, France, 44880
        • Site n°39
      • Segre, France, 49500
        • Site n°13
      • St Etienne de Montluc, France, 44360
        • Site n°38
      • Tierce, France, 49125
        • Site n°75
      • Tierce, France, 49125
        • Site n°77
      • Vihiers, France, 49310
        • Site n°20
      • le Temple de Bretagne, France, 44360
        • Site n°35
  • Romania
      • Brasov, Romania
        • Site n°64
      • Bucharest, Romania, 010243
        • Site n°61
      • Bucharest, Romania, Sector 2
        • Site n°60
      • Bucharest, Romania, Sector 2
        • Site n°63
      • Bucharest, Romania
        • Site n°62
      • Craiova, Romania
        • Site n°65
  • Tunisia
      • Bab Sâadoun Tunis, Tunisia, 1029
        • Site n°52
      • Bab Sâadoun Tunis, Tunisia, 1029
        • Site n°53
      • Tunis, Tunisia, 1007
        • Site n°50
      • Tunis, Tunisia, 1007
        • Site n°51
      • Tunis, Tunisia, 1089
        • Site n°55

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Matching placebo
Drug: Placebo
hard gelatin capsules, oral administration, 4 capsules per day before breakfast
EXPERIMENTAL: GFT505 80mg
Drug: GFT505 80mg
hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in serum Triglycerides (TG) level
Time Frame: 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)
28 days
Increase in serum High Density Lipoprotein Cholesterol (HDL-C) level
Time Frame: 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)
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels
Time Frame: 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)
28 days
Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels
Time Frame: 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)
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genfit

Investigators

  • Study Chair: Eric BRUCKERT, Pr., University Hospital of Paris 6, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (ESTIMATE)

January 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2011

Last Update Submitted That Met QC Criteria

January 6, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFT505-208-3
  • 2008-005779-86 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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