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

NCT01271777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-09-24

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Rémy Hanf, Development Director · Genfit, France

  • Bertrand CARIOU, Pr. · University Hospital of Nantes, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271777 on ClinicalTrials.gov