NCT01275469

Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.

A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days.

Detailed description

The study period is 13 weeks maximum per patient : A screening period (1 to 6-weeks) will precede a 5-week double-blind treatment period and a 2-week follow-up period. The duration of the screening period will depend on the necessity to introduce a wash-out for lipid-lowering drugs : 4-week wash-out from statins and other lipid regulating drugs and 6-week wash-out from fibrates. During the screening period, patients will be asked to start or continue adequate diet and exercise.

Conditions

• Impaired Glucose Tolerance
• 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: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2011-01-12
• Last updated: 2011-01-12

Locations

20 sites across 1 country: France