Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

September 9, 2020 updated by: NGM Biopharmaceuticals, Inc

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Multiple-center Study With Additional Open-label Single-blind and Placebo-controlled 24-Week Histology Cohorts to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for Up to 24 Weeks in Patients With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • NGM Clinical Study Site 703
    • South Australia
      • Adelaide, South Australia, Australia
        • NGM Clinical Study Site 704
    • Victoria
      • Melbourne, Victoria, Australia
        • NGM Clinical Study Site 701
      • Melbourne, Victoria, Australia
        • NGM Clinical Study Site 705
  • Puerto Rico
      • San Juan, Puerto Rico
        • NGM Clinical Study Site 916
  • United States
    • Arizona
      • Chandler, Arizona, United States
        • NGM Clinical Study Site 922
      • Tucson, Arizona, United States
        • NGM Clinical Study Site 923
    • California
      • Los Angeles, California, United States
        • NGM Clinical Study Site 924
      • San Diego, California, United States
        • NGM Clinical Study Site 901
    • Colorado
      • Denver, Colorado, United States
        • NGM Clinical Study Site 902
    • Florida
      • Lakewood Ranch, Florida, United States
        • NGM Clinical Study Site 917
    • Illinois
      • Chicago, Illinois, United States
        • NGM Clinical Study Site 906
    • Missouri
      • Kansas City, Missouri, United States
        • NGM Clinical Study Site 918
    • North Carolina
      • Durham, North Carolina, United States
        • NGM Clinical Study Site 903
    • Tennessee
      • Germantown, Tennessee, United States
        • NGM Clinical Study Site 921
    • Texas
      • Dallas, Texas, United States
        • NGM Clinical Study Site 910
      • Rollingwood, Texas, United States
        • NGM Clinical Study Site 920
      • San Antonio, Texas, United States
        • NGM Clinical Study Site 905
      • San Antonio, Texas, United States
        • NGM Clinical Study Site 909
    • Virginia
      • Charlottesville, Virginia, United States
        • NGM Clinical Study Site 904
      • Richmond, Virginia, United States
        • NGM Clinical Study Site 911
    • Washington
      • Seattle, Washington, United States
        • NGM Clinical Study Site 908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Cohort 1 - Placebo
Other: Placebo
Experimental: Cohort 1 - NGM282 3mg
Biological: NGM282
Experimental: Cohort 1 - NGM282 6mg
Biological: NGM282
Experimental: Cohort 2 - NGM282 0.3mg
Biological: NGM282
Placebo Comparator: Cohort 2 - NGM282 1mg
Biological: NGM282
Experimental: Cohort 2 - NGM282 3mg
Biological: NGM282
Experimental: Cohort 3 - NGM282 1mg
Biological: NGM282
Placebo Comparator: Cohort 4 - Placebo
Other: Placebo
Experimental: Cohort 4 - NGM282 1mg
Biological: NGM282

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in absolute liver fat content as measured by MRI from Baseline to Week 24
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in percentage liver fat content as measure by MRI from Baseline to Week 24
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NGM Biopharmaceuticals, Inc

Collaborators

NGM Biopharmaceuticals Australia Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2015

Primary Completion (Actual)

December 6, 2019

Study Completion (Actual)

January 17, 2020

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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