Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

NGM Biopharmaceuticals, Inc254 enrolled

Overview

The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

254

Conditions

Nonalcoholic Steatohepatitis (NASH)

Interventions

NGM282BIOLOGICAL

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females, between 18 and 75 years of age, inclusive * Histologically confirmed NASH diagnosis Exclusion Criteria: * Clinically significant acute or chronic liver disease * Prior liver transplantation

Locations (22)

NGM Clinical Study Site 922

Chandler, Arizona, United States

Outcomes

Primary Outcomes

Change in Absolute Liver Fat Content (Part 1)

Absolute liver fat content was assessed using magnetic resonance imaging (MRI).

Time frame: Up to Week 12

Change in Absolute Liver Fat Content (Part 2)

Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame: Up to Week 12

Change in Absolute Liver Fat Content (Part 3)

Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame: Up to Week 24

Secondary Outcomes

Percentage Change in Liver Fat Content (Part 1)

Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI).

Time frame: Up to Week 12

Change in Absolute Liver Fat Content (Part 2)

Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame: Up to Week 18

Percentage Change in Liver Fat Content (Part 2)

Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame: Up to Week 18

Change in Absolute Liver Fat Content (Part 3)

Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame: Up to Week 30

Data from ClinicalTrials.gov

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