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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genfit
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

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.