Norursodeoxycholic Acid vs. Placebo in NASH
- Registration Number
- NCT05083390
- Lead Sponsor
- Dr. Falk Pharma GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description norUrsodeoxycholic acid 1000 mg/day norUrsodeoxycholic acid 3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1000 mg norUrsodeoxycholic acid 1500 mg/day norUrsodeoxycholic acid 3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg Placebo to norUrsodeoxycholic acid norUrsodeoxycholic acid 3 film-coated tablets once daily for 72 weeks containing placebo to norUrsodeoxycholic acid
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of Vienna, Department of Internal Medicine III
🇦🇹Vienna, Austria