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Completed

NCT Number: NCT01271777

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

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.

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Key information

Conditions

Insulin Resistance Abdominal Obesity Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Site n°1, Nantes, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GFT505 80mg

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Glucose Infusion Rate (GIR)

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Differences in Hepatic Glucose Production (HGP) in each patient

    Time frame: 8 weeks

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

  2. Changes in GIR (Glucose Infusion Rate)

    Time frame: 8 weeks

    To compare the changes from baseline to endpoint in Glucose Infusion Rate (GIR). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period.

  3. Changes in HGP (Hepatic Glucose Production)

    Time frame: 8 weeks

    To compare the changes from baseline to endpoint in Hepatic Glucose Production (HGP). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period.

Sponsors and collaborators

Lead sponsor

Genfit

Industry

Registry information

Official study title

A Pilot Study to Evaluate the Efficacy of GFT505 (80mg) Orally Administered Once Daily for 8 Weeks on Insulin Sensitivity Using a Glucose Clamp Technique and Safety in Male Patients With Insulin Resistance and Abdominal Obesity. A Multicentre, Randomised, Single Blind, Placebo-Controlled, Cross Over Study.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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