Norursodeoxycholic Acid vs. Placebo in NASH

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH

Criteria

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