Study of safety, tolerability and efficacy of a combination treatment of tropifexor (LJN452) & licogliflozin (LIK066) compared to each monotherapy, compared with placebo in adult participants with nonalcoholic steatohepatitis (NASH) and liver fibrosis

Phase 1

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

• Registration Number: EUCTR2019-002324-32-GB
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-23
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Presence of NASH with fibrosis as confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before
randomization. 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
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 325
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

•Type 1 diabetes mellitus
•Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) = 9% 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 < LLN (see central lab manual)
?International Normalized Radio (INR) > ULN
?ALT or AST > 5xULN (in either of the 2 values)
?Total bilirubin > ULN (see central lab manual) (including Gilbert's syndrome)
?Alkaline phosphatase > 300 IU/L (in either of the 2 values during screening)
?History of esophageal varices, ascites or hepatic encephalopathy
?Splenomegaly
?MELD >12

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified