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Completed

NCT Number: NCT04210245

Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)

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

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Key information

Conditions

Compensated Cirrhosis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NGM Clinical Study Site, Camperdown, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aldafermin

Biological

aldafermin

Placebo

Other

Placebo for aldafermin

Primary outcomes

  1. Change From Baseline in Enhanced Liver Fibrosis Score at Week 48

    Time frame: 48 weeks

    Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome.

    ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of <7.7 is none to mild, > 7.7-9.8 is moderate, > 9.8 is severe.

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 24, 2019
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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