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

Genfit

Status and phase

Completed

Phase 2

Conditions

Abdominal Obesity

Insulin Resistance

Treatments

Drug: Placebo

Drug: GFT505 80mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01271777

GFT505-210-6

2010-023219-32 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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)

Enrollment

22 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.