Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH

• Status: Terminated
• Trial end date: 2018-09-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the present study is to assess the effects of LMB763 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

• Presence of NASH by histologic evidence (liver biopsy) and elevated alanine aminotransferase (ALT), OR phenotypic diagnosis of NASH based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

• Current use of obeticholic acid (OCA)

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

• Pregnant or nursing (lactating) women

• Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping study medication

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

• Clinical evidence of hepatic decompensation or severe liver impairment

• Previous diagnosis of other forms of chronic liver disease

• Uncontrolled diabetes mellitus

• History or current diagnosis of ECG abnormalities

• Patients with contraindications to MRI imaging