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

NCT01275469 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2011-01-12

No results posted yet for this study

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.

Conditions

  • Impaired Glucose Tolerance
  • Abdominal Obesity

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

  • Eric BRUCKERT, Pr. · University Hospital of Paris 6, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT01275469 on ClinicalTrials.gov