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Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity

NCT ID: NCT01271777

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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The study period per patient is 26 weeks: a selection period will precede a 8-week treatment period, a 6-week wash out period, a second 8-week treatment period in the second arm of treatment and a 2- week follow-up period.

Schedule:

* Selection visit prior to treatment period (D-14 and D-1)
* D0 : randomisation visit
* Period T1: first period of treatment with GFT505 80mg or placebo for 8 weeks (D1 to D56)
* Wash out period for 6 weeks (D57 to D98)
* Period T2: second period of treatment with GFT505 80mg or placebo for 8 weeks (D99 to D154)
* Follow up period for 2 weeks (D155 to D169)

Conditions

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Insulin Resistance Abdominal Obesity

Keywords

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Pre-diabetes Clamp technique PPARs Insulin resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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GFT505 80mg

Group Type EXPERIMENTAL

GFT505 80mg

Intervention Type DRUG

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

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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GFT505 80mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Genfit

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rémy Hanf, Development Director

Role: STUDY_DIRECTOR

Genfit, France

Bertrand CARIOU, Pr.

Role: STUDY_CHAIR

University Hospital of Nantes, France

Locations

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Site n°1

Nantes, , France

Site Status

Site n°2

Pierre-Bénite, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 23715754 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23703580 (View on PubMed)

Other Identifiers

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2010-023219-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GFT505-210-6

Identifier Type: -

Identifier Source: org_study_id