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

Phase 2

Completed

• Conditions: Insulin Resistance; Abdominal Obesity
• Interventions: Drug: GFT505 80mg; Drug: Placebo

• Registration Number: NCT01271777
• Lead Sponsor: Genfit

Brief 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)

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-21
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GFT505 80mg	GFT505 80mg	-
Matching placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Glucose Infusion Rate (GIR)	8 weeks	To evaluate in each patient the differences in Glucose Infusion Rate (GIR) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design.

Secondary Outcome Measures

Name	Time	Method
Differences in Hepatic Glucose Production (HGP) in each patient	8 weeks	To evaluate in each patient the differences in Hepatic Glucose Production (HGP) measured at the end of 8 weeks treatment periods with GFT505 (80 mg/day per os) or placebo according to a cross-over design.
Changes in GIR (Glucose Infusion Rate)	8 weeks	To compare the changes from baseline to endpoint in Glucose Infusion Rate (GIR). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period.
Changes in HGP (Hepatic Glucose Production)	8 weeks	To compare the changes from baseline to endpoint in Hepatic Glucose Production (HGP). The baseline will be defined as the values of glucose clamp at V2. The same baseline will be used for the 2 periods. End-points will be defined as glucose clamp values at V4 for the first period and as glucose clamp values at V7 for the second period.

Trial Locations

Locations (2)

Site n°1; 🇫🇷 Nantes Cedex 1, France

Site n°2; 🇫🇷 Pierre Bénite, France