NCT01271777

Brief Summary

The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at 80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be made using a glucose clamp technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 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, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

January 4, 2011

Last Update Submit

September 21, 2012

Conditions

Insulin ResistanceAbdominal Obesity

Keywords

Pre-diabetesClamp techniquePPARsInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • Glucose Infusion Rate (GIR)

    To evaluate in each patient the differences in Glucose Infusion Rate (GIR) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design.

    8 weeks

Secondary Outcomes (3)

  • Differences in Hepatic Glucose Production (HGP) in each patient

    8 weeks

  • Changes in GIR (Glucose Infusion Rate)

    8 weeks

  • Changes in HGP (Hepatic Glucose Production)

    8 weeks

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
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Waist circumference ≥94cm.
  • Body Mass Index ≤ 45kg/m2.
  • Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) \> 3.

You may not qualify if:

  • Blood Pressure \> 160 / 95 mmHg.
  • Diabetes mellitus 1 or 2.
  • Historical of bariatric surgery.
  • Patient treated with a lipid-decreasing medication.
  • A fasting plasma triglycerides concentration \> 400mg/dL or a plasma Low Density Lipoprotein Cholesterol (LDL-c)concentration \> 220mg/dL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site n°1

Nantes, 44093, France

Location

Site n°2

Pierre-Bénite, 69310, France

Location

Related Publications (2)

  • Cariou B, Hanf R, Lambert-Porcheron S, Zair Y, Sauvinet V, Noel B, Flet L, Vidal H, Staels B, Laville M. Dual peroxisome proliferator-activated receptor alpha/delta agonist GFT505 improves hepatic and peripheral insulin sensitivity in abdominally obese subjects. Diabetes Care. 2013 Oct;36(10):2923-30. doi: 10.2337/dc12-2012. Epub 2013 May 28.

    PMID: 23715754DERIVED

  • 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

MeSH Terms

Conditions

Insulin ResistanceObesity, AbdominalGlucose Intolerance

Interventions

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

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemia

Study Officials

  • Rémy Hanf, Development Director

    Genfit, France

    STUDY DIRECTOR

  • Bertrand CARIOU, Pr.

    University Hospital of Nantes, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 7, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

FR(2)