Skip to main content
OpenTrials
Completed

NCT Number: NCT01275469

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Impaired Glucose Tolerance Abdominal Obesity Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site n°31, Angers, France

Loading trial locations.

About this study

The study period is 13 weeks maximum per patient : A screening period (1 to 6-weeks) will precede a 5-week double-blind treatment period and a 2-week follow-up period. The duration of the screening period will depend on the necessity to introduce a wash-out for lipid-lowering drugs : 4-week wash-out from statins and other lipid regulating drugs and 6-week wash-out from fibrates. During the screening period, patients will be asked to start or continue adequate diet and exercise.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or post-menopausal female.
  • Waist circumference ≥94cm for male, ≥ 80cm for female.
  • Fasting Plasma Glucose (FPG) between 110 and 126 mg/dl (between 6.1 and 7.0 mmol/l) within 6 months prior to the screening visit.
  • 2-hour glycaemia at OGTT (2hr after a 75g oral glucose load) ≥140 mg/dL (7.8 mmol/l).

Exclusion criteria

  • Body Mass Index (BMI) ≥ 40 kg/m².
  • Blood Pressure > 160 / 95 mmHg.
  • Known Type I or type II Diabetes Mellitus.
  • Glycated haemoglobin (HbA1c) >7%.
  • A fasting TG > 400mg/dl and a LDL-C > 220mg/dl.

Treatment and study plan

GFT505 80mg

Drug

Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.

Placebo

Drug

Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.

Primary outcomes

  1. Oral Glucose test Tolerance (OGTT)

    Time frame: 4 weeks

    To evaluate the change in plasma Glucose 2hr following oral glucose load from baseline to end point. Evaluation will be made during the selection period, prior any drug intake, and 4 weeks (28-34 days) after the first treatment intake.

Secondary outcomes

  1. Volume oxygen maximal (VO2max)

    Time frame: 5 weeks

    To evaluate the efficacy of GFT505 80mg compared with placebo in improving the VO2max at physical exercise test. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.

  2. Respiratory parameters measured during the physical exercise test

    Time frame: 5 weeks

    To describe the changes on others parameters measured during the physical exercise test : Volume carbon dioxide (VCO2), Respiratory quotient (RQ), Lactate concentration. Evaluation will be made during the selection period, prior any drug intake, and 5 weeks after the first treatment intake.

  3. Fasting Glycemia and Insulinemia

    Time frame: 5 weeks

    To describe the changes of fasting glycaemia and insulinemia in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.

  4. HOMA index (Homeostasis Model Assessment)

    Time frame: 5 weeks

    To describe the changes of HOMA index in the two groups. Evaluation will be made the first day prior any drug intake, then 5 weeks after the first treatment intake.

  5. Lipids

    Time frame: 5 weeks

    To describe the changes in Triglycerides (TG), High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C) and non High Density Lipoprotein Cholesterol (non-HDL-C) levels in the two groups. Evaluation will be made the first day prior any drug intake, then 2-3, and 4 weeks after the first treatment intake and 2 weeks after the last treatment intake (follow-up visit).

Sponsors and collaborators

Lead sponsor

Genfit

Industry

Registry information

Official study title

A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jan 12, 2011
Registry last updated
Jan 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.