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A Phase 2b Study of NGM282 in Participants With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT03912532
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Brief Summary:
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of NGM282 Administered for 24 Weeks for the Treatment of Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: NGM282 Dose 1
Administered by subcutaneous injection
Biological: NGM282
NGM282

Experimental: NGM282 Dose 2
Administered by subcutaneous injection
Biological: NGM282
NGM282

Experimental: NGM282 Dose 3
Administered by subcutaneous injection
Biological: NGM282
NGM282

Placebo Comparator: Placebo
Administered by subcutaneous injection
Other: Placebo
Placebo for NGM282




Primary Outcome Measures :
  1. Proportion of participants achieving a histologic treatment effect (histologic response) as determined by the NASH CRN criteria after 24 weeks of NGM282 or matched placebo. [ Time Frame: 24 weeks ]
  2. Evaluate safety and tolerability of NGM282 in participants with NASH as a function of dose level after up to 24 weeks of treatment with NGM282 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with improvement in liver fibrosis by ≥ 1 stage by CRN criteria [ Time Frame: 24 weeks ]
  2. Proportion of subjects achieving NASH resolution as determined by the NASH CRN criteria [ Time Frame: 24 weeks ]


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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:

  1. Histologically confirmed NASH diagnosis as defined by the NASH CRN
  2. Total liver fat content of ≥ 10% as measured by MRI-PDFF

Exclusion Criteria:

  1. Clinically significant acute or chronic liver disease of an etiology other than NASH
  2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis
  3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters
  4. Prior or pending liver transplantation

Other protocol-defined inclusion/exclusion criteria could apply.


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): NCT03912532


Contacts
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Contact: NGM Study Director (650) 243-5555 ngm282@ngmbio.com

  Show 29 Study Locations
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
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Study Director: NGM Study Director NGM Biopharmaceuticals

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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03912532     History of Changes
Other Study ID Numbers: 18-0108
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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