A randomized, double blind, placebo controlled , multicenter, 12 weeks study to assess safety ,tolerability and efficacy of LJN452 in patients with non-alcoholic steatohepatitis
- Conditions
- Health Condition 1: null- Non-alcoholic Steatohepatitis NASH
- Registration Number
- CTRI/2018/06/014509
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1 male/female patients, 18 years or older
2 written informed consent
3 presence of NASH by histological evidence (liver biopsy) and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)
4 Liver fat equal to or higher than 10% by MRI
1 previous exposure to OCA
2 patients taking prohibited medications
3 pregnant or nursing (lactating) women
4 current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
5 uncontrolled diabetes mellitus
6 presence of cirrhosis
7 hepatic decompensation or severe liver impairment
8 previous diagnosis of other forms of chronic liver disease
9 patients with contraindications to MRI imaging
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Adverse event profile of different doses of LJN452 in patients with NASH <br/ ><br>2 Change in Transaminase levelsTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method 1 Change from baseline in percentage of fat in the liver assessed using MRITimepoint: 12 weeks;2 Change from baseline in weightTimepoint: 12 weeks;Change from baseline in biomarker C4Timepoint: 12 weeks;Change from baseline in biomarker FGF19Timepoint: 12 weeks;Change from baseline in BMITimepoint: 12 weeks;Change from baseline in waist-to-hip (WTH) ratioTimepoint: 12 weeks;Change from baseline on fasting lipid profileTimepoint: 12 weeks;Change from baseline on gamma-glutamyl transferase (GGT)Timepoint: 12 weeks;Change from baseline on on markers of liver fibrosisTimepoint: 12 weeks;Determine C2h of LJN452Timepoint: 12 weeks;Determine Ctrough of LJN452Timepoint: 12 weeks;Itch based on a visual analog scale (VAS) rating scaleTimepoint: 12 weeks