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

Primary Purpose

Atherogenic Dyslipidaemia, Abdominal Obesity

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GFT505 80mg
Placebo
Sponsored by
Genfit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherogenic Dyslipidaemia focused on measuring Atherogenic-dyslipidaemia, PPARs

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site n°36
  • Site n°78
  • Site n°79
  • Site n°80
  • Site n°82
  • Site n°21
  • Site n°16
  • Site n°18
  • Site n°14
  • Site n°26
  • Site n°42
  • Site n°45
  • Site n°32
  • Site n°11
  • Site n°30
  • Site n°91
  • Site n°23
  • Site n°35
  • Site n°12
  • Site n°17
  • Site n°74
  • Site n°10
  • Site n°19
  • Site n°40
  • Site n°37
  • Site n°31
  • Site n°34
  • Site n°41
  • Site n°33
  • Site n°1
  • Site n°39
  • Site n°13
  • Site n°38
  • Site n°75
  • Site n°77
  • Site n°20
  • Site n°64
  • Site n°61
  • Site n°60
  • Site n°63
  • Site n°62
  • Site n°65
  • Site n°52
  • Site n°53
  • Site n°50
  • Site n°51
  • Site n°55

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GFT505 80mg

Matching placebo

Arm Description

Outcomes

Primary Outcome Measures

Decrease in serum Triglycerides (TG) level
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
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
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
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)

Full Information

First Posted
January 6, 2011
Last Updated
January 6, 2011
Sponsor
Genfit
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1. Study Identification

Unique Protocol Identification Number
NCT01271751
Brief Title
Pilot Study With GFT505 (80mg) in Atherogenic Dyslipidaemic Patients With Abdominal Obesity
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genfit

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherogenic Dyslipidaemia, Abdominal Obesity
Keywords
Atherogenic-dyslipidaemia, PPARs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GFT505 80mg
Arm Type
Experimental
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GFT505 80mg
Intervention Description
hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
hard gelatin capsules, oral administration, 4 capsules per day before breakfast
Primary Outcome Measure Information:
Title
Decrease in serum Triglycerides (TG) level
Description
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)
Time Frame
28 days
Title
Increase in serum High Density Lipoprotein Cholesterol (HDL-C) level
Description
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)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels
Description
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)
Time Frame
28 days
Title
Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels
Description
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)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémy Hanf, Development Director
Organizational Affiliation
GENFIT, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eric BRUCKERT, Pr.
Organizational Affiliation
University Hospital of Paris 6, France
Official's Role
Study Chair
Facility Information:
Facility Name
Site n°36
City
Aigrefeuille Sur Maine
ZIP/Postal Code
44140
Country
France
Facility Name
Site n°78
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Site n°79
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Site n°80
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Site n°82
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Site n°21
City
Baune
ZIP/Postal Code
49140
Country
France
Facility Name
Site n°16
City
Beaucouze
ZIP/Postal Code
49070
Country
France
Facility Name
Site n°18
City
Briollay
ZIP/Postal Code
49125
Country
France
Facility Name
Site n°14
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Site n°26
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Site n°42
City
Haute Goulaine
ZIP/Postal Code
44115
Country
France
Facility Name
Site n°45
City
Heric
ZIP/Postal Code
44810
Country
France
Facility Name
Site n°32
City
La Chapelle Sur Erdre
ZIP/Postal Code
44240
Country
France
Facility Name
Site n°11
City
La Jubaudière
ZIP/Postal Code
49510
Country
France
Facility Name
Site n°30
City
La Montagne
ZIP/Postal Code
44620
Country
France
Facility Name
Site n°91
City
Laval
ZIP/Postal Code
53000
Country
France
Facility Name
Site n°23
City
Le Mesnil en Vallée
ZIP/Postal Code
49410
Country
France
Facility Name
Site n°35
City
le Temple de Bretagne
ZIP/Postal Code
44360
Country
France
Facility Name
Site n°12
City
Les Ponts de Ce
ZIP/Postal Code
49130
Country
France
Facility Name
Site n°17
City
Montreuil Juigne
ZIP/Postal Code
49460
Country
France
Facility Name
Site n°74
City
Montrevault
ZIP/Postal Code
49110
Country
France
Facility Name
Site n°10
City
Murs-Erigné
ZIP/Postal Code
49610
Country
France
Facility Name
Site n°19
City
Murs-Erigné
ZIP/Postal Code
49610
Country
France
Facility Name
Site n°40
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Site n°37
City
Nantes
ZIP/Postal Code
44100
Country
France
Facility Name
Site n°31
City
Nantes
ZIP/Postal Code
44300
Country
France
Facility Name
Site n°34
City
Nantes
ZIP/Postal Code
44300
Country
France
Facility Name
Site n°41
City
Nort sur Erdre
ZIP/Postal Code
44390
Country
France
Facility Name
Site n°33
City
Orvault
ZIP/Postal Code
44700
Country
France
Facility Name
Site n°1
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Site n°39
City
Sautron
ZIP/Postal Code
44880
Country
France
Facility Name
Site n°13
City
Segre
ZIP/Postal Code
49500
Country
France
Facility Name
Site n°38
City
St Etienne de Montluc
ZIP/Postal Code
44360
Country
France
Facility Name
Site n°75
City
Tierce
ZIP/Postal Code
49125
Country
France
Facility Name
Site n°77
City
Tierce
ZIP/Postal Code
49125
Country
France
Facility Name
Site n°20
City
Vihiers
ZIP/Postal Code
49310
Country
France
Facility Name
Site n°64
City
Brasov
Country
Romania
Facility Name
Site n°61
City
Bucharest
ZIP/Postal Code
010243
Country
Romania
Facility Name
Site n°60
City
Bucharest
ZIP/Postal Code
Sector 2
Country
Romania
Facility Name
Site n°63
City
Bucharest
ZIP/Postal Code
Sector 2
Country
Romania
Facility Name
Site n°62
City
Bucharest
Country
Romania
Facility Name
Site n°65
City
Craiova
Country
Romania
Facility Name
Site n°52
City
Bab Sâadoun Tunis
ZIP/Postal Code
1029
Country
Tunisia
Facility Name
Site n°53
City
Bab Sâadoun Tunis
ZIP/Postal Code
1029
Country
Tunisia
Facility Name
Site n°50
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
Site n°51
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
Site n°55
City
Tunis
ZIP/Postal Code
1089
Country
Tunisia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23703580
Citation
Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.
Results Reference
derived
PubMed Identifier
21816979
Citation
Cariou B, Zair Y, Staels B, Bruckert E. Effects of the new dual PPAR alpha/delta 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. doi: 10.2337/dc11-0093. Epub 2011 Aug 4.
Results Reference
derived

Learn more about this trial

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

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