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Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT02443116
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
NGM Biopharmaceuticals Australia Pty Ltd
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis (NASH) Biological: NGM282 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 31, 2015
Actual Primary Completion Date : December 6, 2019
Actual Study Completion Date : January 17, 2020

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Cohort 1 - Placebo
Cohort 1 - Placebo
 Other: Placebo
Experimental: Cohort 1 - NGM282 3mg
Cohort 1 - NGM282 3mg
 Biological: NGM282
Experimental: Cohort 1 - NGM282 6mg
Cohort 1 - NGM282 6mg
 Biological: NGM282
Experimental: Cohort 2 - NGM282 0.3mg
Cohort 2 - NGM282 0.3mg
 Biological: NGM282
Placebo Comparator: Cohort 2 - NGM282 1mg
Cohort 2 - NGM282 1mg
 Biological: NGM282
Experimental: Cohort 2 - NGM282 3mg
Cohort 2 - NGM282 3mg
 Biological: NGM282
Experimental: Cohort 3 - NGM282 1mg
Cohort 3 - NGM282 1mg
 Biological: NGM282
Placebo Comparator: Cohort 4 - Placebo
Cohort 4 - Placebo
 Other: Placebo
Experimental: Cohort 4 - NGM282 1mg
Cohort 4 - NGM282 1mg
 Biological: NGM282


Outcome Measures
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Primary Outcome Measures :
  1. Change in absolute liver fat content as measured by MRI from Baseline to Week 24 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change in percentage liver fat content as measure by MRI from Baseline to Week 24 [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443116


Locations
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Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
NGM Biopharmaceuticals Australia Pty Ltd
Investigators
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Study Director: NGM Study Director NGM Biopharmaceuticals, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02443116    
Other Study ID Numbers: 15-0105
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases