Clareo Health | Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
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 treatment. The study duration from first dose of study medication was 52 weeks.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
1. NASH using NAFLD Activity Score (NAS) ≥ 4 with at least 1 point each in inflammation and ballooning and
2. Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria
You may not be if
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
