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Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT02443116
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
NGM Biopharmaceuticals Australia Pty Ltd
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 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)
Study Start Date : May 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: NGM282 Dose 1
NGM282
Biological: NGM282
Experimental: NGM282 Dose 2
NGM282
Biological: NGM282
Experimental: NGM282 Dose 3
NGM282
Biological: NGM282
Experimental: NGM282 Dose 4
NGM282
Biological: NGM282
Placebo Comparator: Placebo
Placebo
Other: Placebo
Experimental: NGM282 Dose 5
NGM282
Biological: NGM282



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 ]


Information from the National Library of Medicine

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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

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


Contacts
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Contact: Bryan Baxter 650-243-5554 bbaxter@ngmbio.com

  Show 22 Study Locations
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
NGM Biopharmaceuticals Australia Pty Ltd
Investigators
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Study Director: Stephen J Rossi, PharmD NGM Biopharmaceuticals, Inc

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     History of Changes
Other Study ID Numbers: 15-0105
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases