Study of safety, tolerability and efficacy of a combination treatment of tropifexor (LJN452) & licogliflozin (LIK066) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis
- Conditions
- on-alcoholic Steatohepatitis (NASH)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-002324-32-IT
- Lead Sponsor
- OVARTIS PHARMA AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 233
Presence of NASH as demonstrated by the following: NASH with fibrosis stage 2 or 3 confirmed by central reader's evaluation using NAFLD Activity Score (NAS) and NASH CRN criteria, of liver biopsy obtained no more than 6 months before randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
•Type 1 diabetes mellitus
•Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) = 9.5% at screening
•HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas
•Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:
¿Abnormal platelet count
¿Serum albumin < 3.2g/dL
¿International Normalized Radio (INR) > 1.3
¿ALT or AST > 5xULN
¿Total bilirubin >1.3 mg/dL (22 µmol/L) (including Gilbert's syndrome)
¿Alkaline phosphatase > 300 IU/L
¿History of esophageal varices, ascites or hepatic encephalopathy
¿Splenomegaly
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method