Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)

• Status: Terminated
• Trial end date: 2020-04-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• male/female patients, 18 years or older

• written informed consent

• Part A and B patients : presence of NASH by histological evidence (liver biopsy obtained 2 years or less prior to randomization) with fibrosis level of F1, F2 or F3 (fibrosis in the absence of cirrhosis) and no diagnosis of chronic liver disease and elevated alanine aminotransferase (ALT) OR phenotypic diagnosis based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus (DM)

• Part C patients: presence of NASH by histological evidence (liver biopsy obtained during the Screening period or 6 months or less prior to randomization) with fibrosis level of F2 or F3 and no diagnosis of chronic liver disease

And ( All Parts):

• ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)

• Liver fat equal to or higher than 10% by MRI

Exclusion Criteria:

• previous exposure to OCA

• patients taking prohibited medications

• patients taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 1 month before randomization: (for Part C patients, dose must be stable for at least 1 month prior to biopsy through Screening : anti- diabetic medications, insulin, beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 200 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control

• pregnant or nursing (lactating) women

• current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening

• uncontrolled diabetes mellitus

• new use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide within 3 months of screening

• presence of cirrhosis

• hepatic decompensation or severe liver impairment

• previous diagnosis of other forms of chronic liver disease

• patients with contraindications to MRI imaging