Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin Compared to Each Monotherapy, in Adult Patients With NASH and Liver Fibrosis
- Conditions
- Health Condition 1: - Health Condition 2: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2020/08/027184
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Presence of NASH as demonstrated by the following NASH with fibrosis stage 2 or 3 confirmed by central readers evaluation using NAFLD Activity Score(NAS)and NASH CRN criteria,of liver biopsy obtained no more than 6 months before randomization.
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
Alkaline phosphatase > 300 IU/L
History of esophageal varices, ascites or hepatic encephalopathy
Splenomegaly
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method