Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
363 participants
INTERVENTIONAL
2019-07-08
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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norUrsodeoxycholic acid 1500 mg/day
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg
norUrsodeoxycholic acid
500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day
norUrsodeoxycholic acid 1000 mg/day
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1000 mg
norUrsodeoxycholic acid
500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day
Placebo to norUrsodeoxycholic acid
3 film-coated tablets once daily for 72 weeks containing placebo to norUrsodeoxycholic acid
norUrsodeoxycholic acid
500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day
Interventions
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norUrsodeoxycholic acid
500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Trauner, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna, Department of Internal Medicine III
Locations
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Medical University of Vienna, Department of Internal Medicine III
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NUT-3/NAS
Identifier Type: -
Identifier Source: org_study_id
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