Non-Alcoholic Steatohepatitis (NASH)


A phase 2b, dose-ranging, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of GS-6624, a monoclonal antibody against lysyl oxidase-like 2 (LOXL2), in subjects with advanced liver fibrosis but not cirrhosis secondary to non-alcoholic steatohepatitis (NASH)

Enrollment status: OPEN

Objective

To determine if injectable study drug (simtuzumab, GS-6624) is effective at preventing the progression of liver fibrosis in subjects with non-cirrhotic NASH

Inclusion criteria

  • 18–65 years old

  • NASH with stage 3–4 fibrosis by Ishak score

  • AST and ALT ≤ 10 x ULN

  • Creatinine < 2.0 mg/dL

Exclusion Criteria

  • Cirrhosis

  • Acites/hepatic encephalopathy/prolonged PT or INR

  • Weight reduction surgery

  • Hepatitis B or C positive

Study Design

  • Subjects randomized to placebo or one of two treatment arms
  • Study duration: 2 years
  • Subjects will receive weight counseling and 3 liver biopsies over the course of the study
  • Subjects will receive $50 per visit

Contacts for referrals or questions:

Principal investigator: Robert Fontana, MD rfontana@med.umich.edu