Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
A Phase 2, Randomized, Double-blind, Placebo-controlled Study With Additional Open-label, Single-blind and Placebo-controlled Cohorts to Assess the Safety, Tolerability, and Efficacy of NGM282 in Patients With Nonalcoholic Steatohepatitis
1 other identifier
interventional
254
3 countries
22
Brief Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedStudy Start
First participant enrolled
July 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2020
CompletedResults Posted
Study results publicly available
June 26, 2025
CompletedJuly 23, 2025
July 1, 2025
4.4 years
May 11, 2015
March 11, 2025
July 11, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Change in Absolute Liver Fat Content (Part 1)
Absolute liver fat content was assessed using magnetic resonance imaging (MRI).
Up to Week 12
Change in Absolute Liver Fat Content (Part 2)
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Up to Week 12
Change in Absolute Liver Fat Content (Part 3)
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Up to Week 24
Secondary Outcomes (5)
Percentage Change in Liver Fat Content (Part 1)
Up to Week 12
Change in Absolute Liver Fat Content (Part 2)
Up to Week 18
Percentage Change in Liver Fat Content (Part 2)
Up to Week 18
Change in Absolute Liver Fat Content (Part 3)
Up to Week 30
Percentage Change in Liver Fat Content (Part 3)
Up to Week 30
Study Arms (9)
Cohort 1 - Placebo
PLACEBO COMPARATORCohort 1 - Placebo
Cohort 1 - NGM282 3mg
EXPERIMENTALCohort 1 - NGM282 3mg
Cohort 1 - NGM282 6mg
EXPERIMENTALCohort 1 - NGM282 6mg
Cohort 2 - NGM282 0.3mg
EXPERIMENTALCohort 2 - NGM282 0.3mg
Cohort 2 - NGM282 1mg
PLACEBO COMPARATORCohort 2 - NGM282 1mg
Cohort 2 - NGM282 3mg
EXPERIMENTALCohort 2 - NGM282 3mg
Cohort 3 - NGM282 1mg
EXPERIMENTALCohort 3 - NGM282 1mg
Cohort 4 - Placebo
PLACEBO COMPARATORCohort 4 - Placebo
Cohort 4 - NGM282 1mg
EXPERIMENTALCohort 4 - NGM282 1mg
Interventions
Eligibility Criteria
You may qualify if:
- Males or females, between 18 and 75 years of age, inclusive
- Histologically confirmed NASH diagnosis
You may not qualify if:
- Clinically significant acute or chronic liver disease
- Prior liver transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
NGM Clinical Study Site 922
Chandler, Arizona, 85224, United States
NGM Clinical Study Site 923
Tucson, Arizona, 85712, United States
NGM Clinical Study Site 924
Los Angeles, California, 90057, United States
NGM Clinical Study Site 901
San Diego, California, 92103, United States
NGM Clinical Study Site 902
Denver, Colorado, United States
NGM Clinical Study Site 917
Lakewood Rch, Florida, 34211, United States
NGM Clinical Study Site 906
Chicago, Illinois, 60611, United States
NGM Clinical Study Site 918
Kansas City, Missouri, 64131, United States
NGM Clinical Study Site 903
Durham, North Carolina, 27710, United States
NGM Clinical Study Site 921
Germantown, Tennessee, 38138, United States
NGM Clinical Study Site 910
Dallas, Texas, 75246, United States
NGM Clinical Study Site 920
Rollingwood, Texas, 78746, United States
NGM Clinical Study Site 909
San Antonio, Texas, 78229, United States
NGM Clinical Study Site 905
San Antonio, Texas, 78234, United States
NGM Clinical Study Site 904
Charlottesville, Virginia, 22908, United States
NGM Clinical Study Site 911
Richmond, Virginia, 23226, United States
NGM Clinical Study Site 908
Seattle, Washington, 98122, United States
NGM Clinical Study Site 703
Sydney, New South Wales, 2050, Australia
NGM Clinical Study Site 704
Adelaide, South Australia, 5042, Australia
NGM Clinical Study Site 701
Melbourne, Victoria, 3004, Australia
NGM Clinical Study Site 705
Melbourne, Victoria, 3065, Australia
NGM Clinical Study Site 916
San Juan, 00927, Puerto Rico
Related Publications (6)
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.
PMID: 39326675DERIVEDNedrud 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.
PMID: 36318027DERIVEDSanyal 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.
PMID: 33898959DERIVEDLoomba 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.
PMID: 32794259DERIVEDHarrison 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.
PMID: 32781086DERIVEDHarrison 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.
PMID: 29519502DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, Clinical Operations
- Organization
- NGM Biopharmaceuticals, Inc
Study Officials
- STUDY DIRECTOR
NGM Study Director
NGM Biopharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 13, 2015
Study Start
July 31, 2015
Primary Completion
December 6, 2019
Study Completion
January 17, 2020
Last Updated
July 23, 2025
Results First Posted
June 26, 2025
Record last verified: 2025-07