Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

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)

Details

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

Keywords

Compensated Cirrhosis Nonalcoholic Steatohepatitis Liver Cirrhosis Fatty Liver Non-alcoholic Fatty Liver Disease Fibrosis aldafermin Daily 0.3 mg dose Daily 1 mg dose Daily 3 mg dose

Eligibility

For people ages 18-75

Key Inclusion Criteria:

  1. Liver biopsy consistent with fibrosis stage 4 (F4) cirrhosis.
  2. Compensated cirrhosis due to NASH.
  3. Total liver fat content of ≥ 8% as measured by MRI-PDFF.

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.

Locations

  • NGM Clinical Study Site not yet accepting patients
    San Francisco California 94143 United States
  • NGM Clinical Study Site not yet accepting patients
    Fresno California 93720 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NGM Biopharmaceuticals, Inc
ID
NCT04210245
Phase
Phase 2
Study Type
Interventional
Last Updated