Evaluation of the Physiological Stability Variability and Robustness of NIS4

Inclusion Criteria:

• Histologically documented steatohepatitis (NASH) with at least minimal (grade 1)hepatocyte ballooning and inflammation on a biopsy performed in the past year.
• OR, if a biopsy is not available:

1. Presence of metabolic risk factors (see below) AND
2. Documentation of steatosis on imaging (hepatic ultrasound, CT scan or MRI) AND
3. Increased ALT >30 IU/L OR liver stiffness >5 kPa on Fibroscan

• Metabolically stable condition, in particular no weight change >5% in the past 6months, anticipated stable diabetic therapy during the study period
• No other identifiable cause of liver disease
• Patients affiliated to French social security.
• Written informed consent signed by the patient

Exclusion Criteria:

• Patient with Hepatitis B or C.
• Presence of any other form of chronic liver disease
• Average alcohol consumption greater than 20 g/day for females and 30 g/day for malesin the preceding 6 months or history of sustained excessive consumption of alcohol inpast 5 years.
• Severely uncontrolled diabetes (HbA1c>9.5%)
• Recent (within 12 months) or concomitant use of agents known to cause hepaticsteatosis (long-term systemic corticosteroids [>10 days], amiodarone, methotrexate,tamoxifen, tetracycline, high dose oestrogens, valproic acid).
• Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at adose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin orpentoxifylline.
• HIV infection.
• Person not fasted 12 hours (T10, T12, D0).
• Substantial diet modification in the 4 months prior to inclusion.
• Patients judged by the investigator to be unsuitable for inclusion in the study (e.g.,judged by the physician as unlikely to be compliant with the study protocol).
• Pregnant or breastfeeding women.
• Patient under legal protection measure.
• Patient is a participating in another research study