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

Phase 1

• Conditions: on-alcoholic Steatohepatitis (NASH); MedDRA version: 22.0 Level: PT Classification code 10053219 Term: Non-alcoholic steatohepatitis System Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-002324-32-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-11
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

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 165
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

•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