CompletedPhase 2

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

United States160 participantsStarted 2020-03-23

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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.

Change From Baseline in Enhanced Liver Fibrosis Score at Week 48

Timeframe: 48 weeks

NCT IDNCT04210245

SponsorNGM Biopharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-04

Results submitted2024-11-14