Nonalcoholic Steatohepatitis
Conditions
Brief 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.
Interventions
500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with resolution of NASH, assessed by centrally scored liver histology, and no worsening of fibrosis AND/OR improvement of fibrosis, and no worsening of NAS | 72 weeks |
Countries
Austria
Contacts
Primary ContactMichael Stiess, PhD
Outcome results
None listed