Norursodeoxycholic Acid vs. Placebo in NASH

Summary

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.

Eligibility

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

Conditions2

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