Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT02443116
Last Updated: 2025-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2015-07-31
2020-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1 - Placebo
Cohort 1 - Placebo
Placebo
Cohort 1 - NGM282 3mg
Cohort 1 - NGM282 3mg
NGM282
Cohort 1 - NGM282 6mg
Cohort 1 - NGM282 6mg
NGM282
Cohort 2 - NGM282 0.3mg
Cohort 2 - NGM282 0.3mg
NGM282
Cohort 2 - NGM282 1mg
Cohort 2 - NGM282 1mg
NGM282
Cohort 2 - NGM282 3mg
Cohort 2 - NGM282 3mg
NGM282
Cohort 3 - NGM282 1mg
Cohort 3 - NGM282 1mg
NGM282
Cohort 4 - Placebo
Cohort 4 - Placebo
Placebo
Cohort 4 - NGM282 1mg
Cohort 4 - NGM282 1mg
NGM282
Interventions
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NGM282
Placebo
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed NASH diagnosis
Exclusion Criteria
* Prior liver transplantation
18 Years
75 Years
ALL
No
Sponsors
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NGM Biopharmaceuticals Australia Pty Ltd
INDUSTRY
NGM Biopharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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NGM Study Director
Role: STUDY_DIRECTOR
NGM Biopharmaceuticals, Inc
Locations
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NGM Clinical Study Site 922
Chandler, Arizona, United States
NGM Clinical Study Site 923
Tucson, Arizona, United States
NGM Clinical Study Site 924
Los Angeles, California, United States
NGM Clinical Study Site 901
San Diego, California, United States
NGM Clinical Study Site 902
Denver, Colorado, United States
NGM Clinical Study Site 917
Lakewood Rch, Florida, United States
NGM Clinical Study Site 906
Chicago, Illinois, United States
NGM Clinical Study Site 918
Kansas City, Missouri, United States
NGM Clinical Study Site 903
Durham, North Carolina, United States
NGM Clinical Study Site 921
Germantown, Tennessee, United States
NGM Clinical Study Site 910
Dallas, Texas, United States
NGM Clinical Study Site 920
Rollingwood, Texas, United States
NGM Clinical Study Site 909
San Antonio, Texas, United States
NGM Clinical Study Site 905
San Antonio, Texas, United States
NGM Clinical Study Site 904
Charlottesville, Virginia, United States
NGM Clinical Study Site 911
Richmond, Virginia, United States
NGM Clinical Study Site 908
Seattle, Washington, United States
NGM Clinical Study Site 703
Sydney, New South Wales, Australia
NGM Clinical Study Site 704
Adelaide, South Australia, Australia
NGM Clinical Study Site 701
Melbourne, Victoria, Australia
NGM Clinical Study Site 705
Melbourne, Victoria, Australia
NGM Clinical Study Site 916
San Juan, , Puerto Rico
Countries
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References
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Alkhouri N, Beyer C, Shumbayawonda E, Andersson A, Yale K, Rolph T, Chung RT, Vuppalanchi R, Cusi K, Loomba R, Pansini M, Dennis A. Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. J Hepatol. 2025 Mar;82(3):438-445. doi: 10.1016/j.jhep.2024.08.031. Epub 2024 Sep 25.
Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1.
Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.
Loomba R, Ling L, Dinh DM, DePaoli AM, Lieu HD, Harrison SA, Sanyal AJ. The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in NASH. Hepatology. 2021 Jan;73(1):126-143. doi: 10.1002/hep.31523. Epub 2020 Dec 11.
Harrison SA, Neff G, Guy CD, Bashir MR, Paredes AH, Frias JP, Younes Z, Trotter JF, Gunn NT, Moussa SE, Kohli A, Nelson K, Gottwald M, Chang WCG, Yan AZ, DePaoli AM, Ling L, Lieu HD. Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Jan;160(1):219-231.e1. doi: 10.1053/j.gastro.2020.08.004. Epub 2020 Aug 8.
Harrison SA, Rinella ME, Abdelmalek MF, Trotter JF, Paredes AH, Arnold HL, Kugelmas M, Bashir MR, Jaros MJ, Ling L, Rossi SJ, DePaoli AM, Loomba R. NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2018 Mar 24;391(10126):1174-1185. doi: 10.1016/S0140-6736(18)30474-4. Epub 2018 Mar 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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15-0105
Identifier Type: -
Identifier Source: org_study_id
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