Clinical trial NCT02443116: Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis (NASH)
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: NGM Biopharmaceuticals Australia Pty Ltd
First posted: 2015-05-13
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in absolute liver fat content as measured by MRI from Baseline to Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in percentage liver fat content as measure by MRI from Baseline to Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: NGM Clinical Study Site 922
state: Arizona
city: Tucson
country: United States
facility: NGM Clinical Study Site 923
state: Arizona
city: Los Angeles
country: United States
facility: NGM Clinical Study Site 924
state: California
city: San Diego
country: United States
facility: NGM Clinical Study Site 901
state: California
city: Denver
country: United States
facility: NGM Clinical Study Site 902
state: Colorado
city: Lakewood Ranch
country: United States
facility: NGM Clinical Study Site 917
state: Florida
city: Chicago
country: United States
facility: NGM Clinical Study Site 906
state: Illinois
city: Kansas City
country: United States
facility: NGM Clinical Study Site 918
state: Missouri
city: Durham
country: United States
facility: NGM Clinical Study Site 903
state: North Carolina
city: Germantown
country: United States
facility: NGM Clinical Study Site 921
state: Tennessee
city: Dallas
country: United States
facility: NGM Clinical Study Site 910
state: Texas
city: Rollingwood
country: United States
facility: NGM Clinical Study Site 920
state: Texas
city: San Antonio
country: United States
facility: NGM Clinical Study Site 905
state: Texas
city: San Antonio
country: United States
facility: NGM Clinical Study Site 909
state: Texas
city: Charlottesville
country: United States
facility: NGM Clinical Study Site 904
state: Virginia
city: Richmond
country: United States
facility: NGM Clinical Study Site 911
state: Virginia
city: Seattle
country: United States
facility: NGM Clinical Study Site 908
state: Washington
city: Sydney
country: Australia
facility: NGM Clinical Study Site 703
state: New South Wales
city: Adelaide
country: Australia
facility: NGM Clinical Study Site 704
state: South Australia
city: Melbourne
country: Australia
facility: NGM Clinical Study Site 701
state: Victoria
city: Melbourne
country: Australia
facility: NGM Clinical Study Site 705
state: Victoria
city: San Juan
country: Puerto Rico
facility: NGM Clinical Study Site 916
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: NGM Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.