JKB-121 for the Treatment of Nonalcoholic Steatohepatitis

Exclusion Criteria

• •1. Any chronic liver disease other than NASH
• •2. Cirrhosis, as assessed clinically or histologically
• •3. Presence of vascular liver disease
• •4. BMI ≤ 25 kg/m2
• •5. Excessive alcohol use (\> 20 g/day) within the past 2 years
• •6. AST or ALT \> 250 U/L.
• •7. Type 1 diabetes mellitus
• •8. Bariatric surgery in the past 5 years.
• •9. Weight gain of \> 5% in past 6 months or \> 10% change in past 12 months.
• •10. Contraindication to MRI
• •11. Inadequate venous access
• •12. HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or Hepatitis C virus (HCV) RNA positive.
• •13. Receiving an elemental diet or parenteral nutrition
• •14. Chronic pancreatitis or pancreatic insufficiency
• •15. Any history of complications of cirrhosis
• •16. Concurrent conditions:
• •* Inflammatory bowel disease
• •* Significant cardiac disease
• •* chronic infection or immune mediated disease
• •* Any malignant disease
• •* Prior solid organ transplant
• •* Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or the interpretation of the study data.
• •17. Concurrent medications which may treat NASH
• •18. HbA1C \> 9.0%
• •19. Pregnancy or breastfeeding.