Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)

The study duration per patient will be 80 weeks. A screening period (from 4 to 16 weeks)
will precede a 52-week double-blind treatment period and a 3 months follow-up period.

The study will be conducted in 270 patients (90 patients in the placebo arm, 90 patients in
the GFT505 80mg arm, and 90 patients in the GFT505 120mg arm).

Enrollment will be performed in two phases: during the first phase, the patients will
receive either GFT505 at a dose of 80 mg either the placebo. An independent expert committee
will review the safety data when 45 patients receiving the dose at 80 mg will have been
treated for 6 months. The committee approval will be necessary to start the second phase,
while the patients will receive either GFT505 at a dose of 80 mg, or GFT505 at a dose of 120
mg or the placebo.

Inclusion Criteria:

- Males or females (females must be either of non-child bearing potential or using an
efficient double contraception). For male participants, contraceptive measures must
be taken during the study, either by the male participant or his female partner.

- 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 authorized. 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,
neoplastic, 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.