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

Insulin Resistance Clinical Trial

Official 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.

Status Completed

Clinical Trial 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.

Clinical Trial Description

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) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Insulin Resistance
• Obesity
• Obesity, Abdominal

• NCT number: NCT01271777
• Study type: Interventional
• Source: Genfit
• Status: Completed
• Phase: Phase 2
• Start date: January 2011
• Completion date: November 2011