Status:
TERMINATED
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non Alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with pla...
Detailed Description
The study consisted of 1) a screening period, 2) a treatment period starting from randomization on Day 0 and running to Week 48, and 3) a follow-up period of 4 weeks after the last dose of study treat...
Eligibility Criteria
Inclusion
- Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following:
- NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation and ballooning and
- Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria
Exclusion
- Type 1 diabetes mellitus
- Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% 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:
- Platelet count \< LLN (see Central laboratory manual).
- Serum albumin \< LLN (see Central laboratory manual).
- International Normalized Ratio (INR) \> ULN (see Central laboratory manual).
- ALT or AST \> 5× ULN (confirmed by 2 values during screening).
- Total bilirubin \> ULN (see Central laboratory manual) (confirmed by 2 values during screening), including Gilbert's syndrome.
- Alkaline phosphatase \> 300 IU/L (confirmed by 2 values during screening).
- History of esophageal varices, ascites or hepatic encephalopathy
- Splenomegaly
- MELD score \>12
Key Trial Info
Start Date :
December 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04065841
Start Date
December 30 2019
End Date
October 27 2022
Last Update
January 28 2025
Active Locations (80)
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1
Gut PC Digestive Health Specialist
Dothan, Alabama, United States, 36305
2
Southern California Research Center
Coronado, California, United States, 92118
3
Velocity Clinical Trials
Los Angeles, California, United States, 90057
4
California Liver Research Institute
Pasadena, California, United States, 91105