NCT01271751

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
3 countries

47 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
Last Updated

January 7, 2011

Status Verified

January 1, 2011

Enrollment Period

8 months

First QC Date

January 6, 2011

Last Update Submit

January 6, 2011

Conditions

Atherogenic DyslipidaemiaAbdominal Obesity

Keywords

Atherogenic-dyslipidaemiaPPARs

Outcome Measures

Primary Outcomes (2)

  • 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)

    28 days

  • 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)

    28 days

Secondary Outcomes (2)

  • Decrease in Low Density Lipoprotein Cholesterol (LDL-C) levels

    28 days

  • Decrease in non-HDL-C (High Density Lipoprotein Cholesterol) levels

    28 days

Study Arms (2)

GFT505 80mg

EXPERIMENTAL
Drug: GFT505 80mg

Matching placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

GFT505 80mgDRUG

hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast

GFT505 80mg
PlaceboDRUG

hard gelatin capsules, oral administration, 4 capsules per day before breakfast

Matching placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • ≤ 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.

You may not qualify if:

  • Body Mass Index (BMI) ≥ 40 kg/m².
  • Blood Pressure \> 160 / 95 mmHg.
  • Type I or type II Diabetes Mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Site n°36

Aigrefeuille-sur-Maine, 44140, France

Location

Site n°78

Angers, 49000, France

Location

Site n°79

Angers, 49000, France

Location

Site n°80

Angers, 49000, France

Location

Site n°82

Angers, 49000, France

Location

Site n°21

Bauné, 49140, France

Location

Site n°16

Beaucouzé, 49070, France

Location

Site n°18

Briollay, 49125, France

Location

Site n°14

Cholet, 49300, France

Location

Site n°26

Cholet, 49300, France

Location

Site n°42

Haute-Goulaine, 44115, France

Location

Site n°45

Héric, 44810, France

Location

Site n°32

La Chapelle-sur-Erdre, 44240, France

Location

Site n°11

La Jubaudière, 49510, France

Location

Site n°30

La Montagne, 44620, France

Location

Site n°91

Laval, 53000, France

Location

Site n°23

Le Mesnil-en-Vallée, 49410, France

Location

Site n°35

Le Temple-de-Bretagne, 44360, France

Location

Site n°12

Les Ponts-de-Cé, 49130, France

Location

Site n°17

Montreuil-Juigné, 49460, France

Location

Site n°74

Montrevault, 49110, France

Location

Site n°10

Murs-Erigné, 49610, France

Location

Site n°19

Murs-Erigné, 49610, France

Location

Site n°40

Nantes, 44000, France

Location

Site n°37

Nantes, 44100, France

Location

Site n°31

Nantes, 44300, France

Location

Site n°34

Nantes, 44300, France

Location

Site n°41

Nort-sur-Erdre, 44390, France

Location

Site n°33

Orvault, 44700, France

Location

Site n°1

Paris, 75013, France

Location

Site n°38

Saint-Étienne-de-Montluc, 44360, France

Location

Site n°39

Sautron, 44880, France

Location

Site n°13

Segré, 49500, France

Location

Site n°75

Tiercé, 49125, France

Location

Site n°77

Tiercé, 49125, France

Location

Site n°20

Vihiers, 49310, France

Location

Site n°64

Brasov, Romania

Location

Site n°61

Bucharest, 010243, Romania

Location

Site n°60

Bucharest, Sector 2, Romania

Location

Site n°63

Bucharest, Sector 2, Romania

Location

Site n°62

Bucharest, Romania

Location

Site n°65

Craiova, Romania

Location

Site n°52

Bab Sâadoun Tunis, 1029, Tunisia

Location

Site n°53

Bab Sâadoun Tunis, 1029, Tunisia

Location

Site n°50

Tunis, 1007, Tunisia

Location

Site n°51

Tunis, 1007, Tunisia

Location

Site n°55

Tunis, 1089, Tunisia

Location

Related Publications (2)

  • 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.

    PMID: 23703580DERIVED

  • 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.

    PMID: 21816979DERIVED

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rémy Hanf, Development Director

    GENFIT, France

    STUDY DIRECTOR

  • Eric BRUCKERT, Pr.

    University Hospital of Paris 6, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 7, 2011

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

November 1, 2009

Last Updated

January 7, 2011

Record last verified: 2011-01

Locations

FR(36)TU(5)RO(6)