Nonalcoholic Steatohepatitis Clinical Trial
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)
| Verified date | June 2023 |
| Source | NGM Biopharmaceuticals, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | February 23, 2023 |
| Est. primary completion date | January 4, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | NGM Clinical Study Site | Adelaide | South Australia |
| Australia | NGM Clinical Study Site | Bedford Park | South Australia |
| Australia | NGM Clinical Study Site | Camperdown | New South Wales |
| Australia | NGM Clinical Study Site | Clayton | Victoria |
| Australia | NGM Clinical Study Site | Fitzroy | Victoria |
| Australia | NGM Clinical Study Site | Heidelberg | Victoria |
| Australia | NGM Clinical Study Site | Melbourne | Victoria |
| Australia | NGM Clinical Study Site | Westmead | New South Wales |
| Belgium | NGM Clinical Study Site | Brussels | |
| France | NGM Clinical Study Site | Paris | |
| France | NGM Clinical Study Site | Pessac Cedex | |
| Germany | NGM Clinical Study Site | Leipzig | |
| Germany | NGM Clinical Study Site | Leipzig | |
| Hong Kong | NGM Clinical Study Site | Shatin | |
| Poland | NGM Clinical Study Site | Wroclaw | |
| Puerto Rico | NGM Clinical Study Site | San Juan | |
| United Kingdom | NGM Clinical Study Site | London | |
| United States | NGM Clinical Study Site | Austin | Texas |
| United States | NGM Clinical Study Site | Baltimore | Maryland |
| United States | NGM Clinical Study Site | Boca Raton | Florida |
| United States | NGM Clinical Study Site | Boston | Massachusetts |
| United States | NGM Clinical Study Site | Boston | Massachusetts |
| United States | NGM Clinical Study Site | Chicago | Illinois |
| United States | NGM Clinical Study Site | Chicago | Illinois |
| United States | NGM Clinical Study Site | Durham | North Carolina |
| United States | NGM Clinical Study Site | Edinburg | Texas |
| United States | NGM Clinical Study Site | Edinburg | Texas |
| United States | NGM Clinical Study Site | Flowood | Mississippi |
| United States | NGM Clinical Study Site | Fresno | California |
| United States | NGM Clinical Study Site | Germantown | Tennessee |
| United States | NGM Clinical Study Site | Glendale | Arizona |
| United States | NGM Clinical Study Site | Houston | Texas |
| United States | NGM Clinical Study Site | Jackson | Mississippi |
| United States | NGM Clinical Study Site | Kansas City | Missouri |
| United States | NGM Clinical Study Site | La Jolla | California |
| United States | NGM Clinical Study Site | Los Angeles | California |
| United States | NGM Clinical Study Site | Marietta | Georgia |
| United States | NGM Clinical Study Site | Miami | Florida |
| United States | NGM Clinical Study Site | North Little Rock | Arkansas |
| United States | NGM Clinical Study Site | Panorama City | California |
| United States | NGM Clinical Study Site | Rialto | California |
| United States | NGM Clinical Study Site | Richmond | Virginia |
| United States | NGM Clinical Study Site | Richmond | Virginia |
| United States | NGM Clinical Study Site | San Antonio | Texas |
| United States | NGM Clinical Study Site | San Antonio | Texas |
| United States | NGM Clinical Study Site | Seattle | Washington |
| United States | NGM Clinical Study Site | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| NGM Biopharmaceuticals, Inc |
United States, Australia, Belgium, France, Germany, Hong Kong, Poland, Puerto Rico, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in Enhanced Liver Fibrosis (ELF) score. | 48 weeks | ||
| Primary | Safety assessed by reported and observed adverse events. | 48 weeks |
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