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

Genfit47 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Impaired Glucose Tolerance Abdominal Obesity

Interventions

GFT505 80mgDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (20)

Site n°31

Angers, France

Site n°32

Angers, France

Site n°36

Angers, France

Outcomes

Primary Outcomes

Oral Glucose test Tolerance (OGTT)

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.

Time frame: 4 weeks

Secondary Outcomes

Volume oxygen maximal (VO2max)

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.

Time frame: 5 weeks

Respiratory parameters measured during the physical exercise test

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.

Time frame: 5 weeks

Fasting Glycemia and Insulinemia

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.

Time frame: 5 weeks

HOMA index (Homeostasis Model Assessment)

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.

Time frame: 5 weeks

Lipids

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).

Data from ClinicalTrials.gov

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