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Completed

NCT Number: NCT02443116

Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

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

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Key information

Conditions

Nonalcoholic Steatohepatitis (NASH) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NGM Clinical Study Site 703, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGM282

Biological

Placebo

Other

Primary outcomes

  1. Change in Absolute Liver Fat Content (Part 1)

    Time frame: Up to Week 12

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

  2. Change in Absolute Liver Fat Content (Part 2)

    Time frame: Up to Week 12

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

  3. Change in Absolute Liver Fat Content (Part 3)

    Time frame: Up to Week 24

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

Secondary outcomes

  1. Percentage Change in Liver Fat Content (Part 1)

    Time frame: Up to Week 12

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

  2. Change in Absolute Liver Fat Content (Part 2)

    Time frame: Up to Week 18

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

  3. Percentage Change in Liver Fat Content (Part 2)

    Time frame: Up to Week 18

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

  4. Change in Absolute Liver Fat Content (Part 3)

    Time frame: Up to Week 30

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

  5. Percentage Change in Liver Fat Content (Part 3)

    Time frame: Up to Week 30

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

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Collaborators

  • NGM Biopharmaceuticals Australia Pty Ltd

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-controlled Study With Additional Open-label, Single-blind and Placebo-controlled Cohorts to Assess the Safety, Tolerability, and Efficacy of NGM282 in Patients With Nonalcoholic Steatohepatitis

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
May 13, 2015
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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