Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Liver Fibrosis Due to NASH Clinical Trial

Official title: 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 Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Status Terminated

Clinical Trial Summary

The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH.

It will consist of 2 phases:

• Randomized Double-Blind Phase

• Open-Label Phase (optional)

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis Due to NASH
• Non-alcoholic Fatty Liver Disease

• NCT number: NCT01672866
• Study type: Interventional
• Source: Gilead Sciences
• Status: Terminated
• Phase: Phase 2
• Start date: December 5, 2012
• Completion date: December 29, 2016