Norursodeoxycholic Acid vs. Placebo in NASH

Double-blind, Randomised, Placebo-controlled, Phase IIb Trial on the Efficacy and Safety of Norursodeoxycholic Acid Tablets in Patients With Non-alcoholic Steatohepatitis (NASH)

This is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase IIb trial. The trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d or 1000 mg/d norUDCA tablets vs. placebo tablets for the treatment of NASH.

Inclusion Criteria:

• Must be willing to participate in the study and provide written informed consent
• Male or female patients ≥ 18 and < 75 years
• Centrally assessed histological evidence of NASH and liver fibrosis
• Women of childbearing potential agree to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment

Exclusion Criteria:

• Patients taking prohibited medications
• Presence of liver cirrhosis
• Type 1 diabetes or uncontrolled Type 2 diabetes
• History or presence of any other significant concomitant liver diseases
• History of liver transplantation
• BMI >45 kg/m^2
• Any known relevant infectious disease (e.g., active tuberculosis, acquired immunodeficiency syndrome [AIDS]-defining diseases)
• Abnormal renal function (glomerular filtration rate estimated from cystatin C < 30 ml/min) at screening visit
• Any active malignant disease (except for basal cell carcinoma)
• Existing or intended pregnancy or breast-feeding