Phase 2
Completed N=160
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
Source: ClinicalTrials.gov NCT04210245 ↗Enrolled (actual)
160
Serious AEs
11.9%
Results posted
Mar 2025
Primary outcomePrimary: Change From Baseline in Enhanced Liver Fibrosis Score at Week 48 — -0.071; 0.125; -0.213; 0.263 score on a scale
Summary
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Enhanced Liver Fibrosis Score at Week 48 |
-0.071; 0.125; -0.213; 0.263 | — |
Eligibility Criteria
Key Inclusion Criteria
- Liver biopsy consistent with NASH cirrhosis.
- Compensated cirrhosis due to NASH.
Key Exclusion Criteria
- 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.
- Evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis.
- History of hepatic decompensation including variceal bleeding, ascites, or hepatic encephalopathy.
- Model of end stage liver disease (MELD) score >12.
Other protocol-defined inclusion/exclusion criteria could apply.
Data sourced from ClinicalTrials.gov (NCT04210245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.