Clinical trial NCT04210245: Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
Official title: Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Compensated Cirrhosis
Nonalcoholic Steatohepatitis
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 160
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: A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

Detailed description: The study will compare multiple doses of aldafermin against placebo in a compensated NASH cirrhosis population for 48 weeks of treatment.

Eligibility criteria: Key Inclusion Criteria:

1. Liver biopsy consistent with NASH cirrhosis.
2. Compensated cirrhosis due to NASH.

Key Exclusion Criteria:

1. Other causes of liver disease including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, primary biliary cirrhosis, drug-induced hepatotoxicity, Wilson's disease, hemochromatosis, and alpha-1-anti-trypsin definition based on medical history and/or centralized read of liver histology.
2. Evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis.
3. History of hepatic decompensation including variceal bleeding, ascites, or hepatic encephalopathy.
4. Model of end stage liver disease (MELD) score \>12.

Other protocol-defined inclusion/exclusion criteria could apply.

Primary outcomes:
measure: Change From Baseline in Enhanced Liver Fibrosis Score at Week 48
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: NGM Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: NGM Clinical Study Site 413
state: Arizona
city: Tucson
country: United States
facility: NGM Clinical Study Site 415
state: Arizona
city: North Little Rock
country: United States
facility: NGM Clinical Study Site
state: Arkansas
city: Fresno
country: United States
facility: NGM Clinical Study Site
state: California
city: La Jolla
country: United States
facility: NGM Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: NGM Clinical Study Site
state: California
city: Panorama City
country: United States
facility: NGM Clinical Study Site
state: California
city: Rialto
country: United States
facility: NGM Clinical Study Site
state: California
city: Boca Raton
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Miami
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Marietta
country: United States
facility: NGM Clinical Study Site
state: Georgia
city: Chicago
country: United States
facility: NGM Clinical Study Site
state: Illinois
city: Chicago
country: United States
facility: NGM Clinical Study Site
state: Illinois
city: Baltimore
country: United States
facility: NGM Clinical Study Site
state: Maryland
city: Boston
country: United States
facility: NGM Clinical Study Site
state: Massachusetts
city: Boston
country: United States
facility: NGM Clinical Study Site
state: Massachusetts
city: Flowood
country: United States
facility: NGM Clinical Study Site
state: Mississippi
city: Jackson
country: United States
facility: NGM Clinical Study Site 488
state: Mississippi
city: Kansas City
country: United States
facility: NGM Clinical Study Site
state: Missouri
city: Durham
country: United States
facility: NGM Clinical Study Site
state: North Carolina
city: Germantown
country: United States
facility: NGM Clinical Study Site
state: Tennessee
city: Austin
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Edinburg
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Edinburg
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Houston
country: United States
facility: NGM Clinical Study Site 481
state: Texas
city: San Antonio
country: United States
facility: NGM Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Richmond
country: United States
facility: NGM Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: NGM Clinical Study Site
state: Virginia
city: Seattle
country: United States
facility: NGM Clinical Study Site 482
state: Washington
city: Camperdown
country: Australia
facility: NGM Clinical Study Site
state: New South Wales
city: Westmead
country: Australia
facility: NGM Clinical Study Site
state: New South Wales
city: Adelaide
country: Australia
facility: NGM Clinical Study Site
state: South Australia
city: Bedford Park
country: Australia
facility: NGM Clinical Study Site
state: South Australia
city: Clayton
country: Australia
facility: NGM Clinical Study Site
state: Victoria
city: Fitzroy
country: Australia
facility: NGM Clinical Study Site
state: Victoria
city: Heidelberg
country: Australia
facility: NGM Clinical Study Site
state: Victoria
city: Melbourne
country: Australia
facility: NGM Clinical Study Site
state: Victoria
city: Brussels
country: Belgium
facility: NGM Clinical Study Site
city: Paris
country: France
facility: NGM Clinical Study Site
city: Pessac Cedex
country: France
facility: NGM Clinical Study Site
city: Leipzig
country: Germany
facility: NGM Clinical Study Site
city: Leipzig
country: Germany
facility: NGM Clinical Study Site
city: Shatin
country: Hong Kong
facility: NGM Clinical Study Site
city: Wroclaw
country: Poland
facility: NGM Clinical Study Site 444
city: Wroclaw
country: Poland
facility: NGM Clinical Study Site 446
city: San Juan
country: Puerto Rico
facility: NGM Clinical Study Site
city: London
country: United Kingdom
facility: NGM Clinical Study Site 466
Study officials:
affiliation: NGM Biopharmaceuticals
name: NGM Study Director
role: STUDY_DIRECTOR
References: