Conditions: Nonalcoholic Steatohepatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced Fibrosis

Detailed description:
The primary objective is to determine the difference between placebo and GR-MD-02 treatment in the baseline adjusted mean change in liver fibrosis as measured by corrected T1 (cT1) mapping as determined from LiverMultiScan (LMS), a multi-parametric MRI protocol.

Secondary objectives include evaluating differences between subjects treated with GR-MD-02 versus placebo in:

* The baseline-adjusted change in liver stiffness as measured by MR-elastography
* The baseline-adjusted change in liver stiffness as measured by FibroScan® scores.

An exploratory objective will be to evaluate the correlation of the three diagnostic modalities of LiverMultiScan, MR-Elastography, and FibroScan®.

Arms:
arm 1: Active arm 2: Placebo

Interventions: intervention 1: GR-MD-02 intervention 2: Placebo
Intervention descriptions: intervention 1: GM-MD-02 active intervention 2: Placebo

Protocol document: