NCT01271777

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Genfit · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Insulin Resistance
• Abdominal Obesity

Interventions

Type	Name	Description
DRUG	GFT505 80mg	hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
DRUG	Placebo	hard gelatin capsules, oral administration, 4 capsules per day before breakfast

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-01-07
• Last updated: 2012-09-24

Locations

2 sites across 1 country: France