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

NUT-3/NAS

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.

2019-07-08

2025-01-01

2025-04-01

Recruiting

Early phase I

363

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 363, 'type': 'ESTIMATED'}}

2024-02-20