A Study to Evaluate the Efficacy and Safety of GFT505 Once Daily on Steatohepatitis in Patients With Non-Alcoholic Steatohepatitis (NASH). A Multicentre, Randomized, Double Blind, Placebo-Controlled Study, With an Adaptive Design to Allow for Initial GFT505 80mg Dosing Versus Placebo, Followed by a Second Phase Including GFT505 120mg Dose, After Review of 6-month Safety Analysis of the 80mg Data on at Least 50% of Patients.

Inclusion Criteria:

- Males or females (females must be either of non-child bearing potential or using an
efficient double contraception).

- Body Mass Index ≤ 45 kg/m².

- Patients agree to have one liver biopsy during the screening period for diagnostic
purpose (if no historical biopsy within 6 months before randomization is available)
and one at the end of the treatment period for assessment of the treatment effects.

- For hypertensive patients, hypertension must be controlled by stable dose of
anti-hypertensive medication for at least 2 months prior to screening (and the stable
dose can be maintained throughout the study).

- Patients treated with vitamin E (>400IU/d), or Polyunsaturated fatty acids
(>2g/day)or Ursodeoxycholic acid can be included if drugs are stopped at least 3
months prior to diagnostic liver biopsy and up to the end of the study.

- Histological confirmation of steatohepatitis on a diagnostic liver biopsy.
Histological diagnostic is confirmed by central reading of the slides (steatosis > 5%
+ lobular inflammation, any grade + ballooning, any amount).

- For patients with Type 2 Diabetes, glycemia must be controlled (Glycosylated
Haemoglobin A1c ≤8.5%). If glycemia is controlled by anti-diabetic drugs, qualitative
change is not permitted within 6 months prior to randomization and should be avoided
during the study. Treatments with metformin, Dipeptidyl Peptidase 4 inhibitors,
Glucagon-like peptide-1 agonists, sulfamides, insulin are authorised. Sulfamides and
insulin are permitted if glycemia is self-monitored by the patient.

Exclusion Criteria:

- Known heart failure (Grade I to IV of New York Heart Association classification).

- Weight loss of more than 5% within 6 months prior to randomization.

- History of bariatric surgery.

- Uncontrolled Blood Pressure.

- Type 1 diabetes patients.

- Patients who had an acute cardiovascular episode within the 6 months prior to
screening, or with a history of coronary angioplasty, history of stroke, Transient
Ischemic Attack, Coronary Heart Disease.

- Compensated and uncompensated cirrhosis. Notably, NASH patients with fibrosis stage =
4 according to the NASH CRN fibrosis staging system are excluded.

- Known alcohol and/or any other drug abuse or dependence in the last five years.

- Pregnant or lactating females.

- Other well documented causes of chronic liver disease

- Known intolerance or contra-indication to the list of excipients of GFT505.

- Evidence of any other unstable or, untreated clinically significant immunological,
neoplasic, endocrine, haematological, gastrointestinal, neurological or psychiatric
disorder.

- Positive HBsAg (Hepatitis B Surface Antigen), Positive anti-HIV, positive HCV-RNA
(Hepatitis C Virus).

- Uncontrolled hypothyroidism defined as Thyroid Stimulating Hormone > 2X the upper
limit of normal (ULN). Thyroid dysfunction controlled for at least 6 months prior to
screening is permitted.

- Significant renal disease, including nephritic syndrome, chronic renal failure
(defined as creatinine clearance < 60 mL/mn and serum creatinine >180 μmol/L).

- Unexplained serum creatine phosphokinase (CPK) > 3X the upper limit of normal (ULN).
Patients with a reason for CPK elevation may have the measurement repeated prior to
randomization; a CPK retest > 3X ULN leads to exclusion.