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) - ALPINE 4

GM Biopharmaceuticals, Inc.0 sites150 target enrollmentApril 16, 2020

Overview

No summary available.

Registry

who.int

Start Date

April 16, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

GM Biopharmaceuticals, Inc.

•1\. Males and females from 18 to 75 years of age who are able to comprehend and willing to sign an Informed Consent Form (ICF).
•2\. Liver biopsy consistent with a diagnosis of NASH and Fibrosis Stage 4 (F4\) Cirrhosis according to NASH CRN criteria and per the central pathologist evaluation.
•a. A historical biopsy is acceptable if tissue slides are available from within 12 months prior to Screening and are acceptable for the central pathologist evaluation.
•b. Liver biopsies must be consistent with a diagnosis of NASH as defined by: hepatocellular ballooning, steatosis, and lobular inflammation according to the NAS and determined by the central pathologist evaluation, minimum 1 point in each category.
•c. NASH must be the etiology of cirrhosis (i.e., no other causes of cirrhosis)
•3\. Criterion deleted per Protocol Version 5\.2
•4\. Subjects must have Definitive NASH cirrhosis as defined in Noureddin 2020\. (refer to Protocol)
•5\. AFP \= 20 ng/mL at Screening.
•6\. Negative for hepatic lesions/nodules indicating HCC risk
•a. MRI is the preferred imaging modality. There must be no nodules with a Liver Imaging and Reporting Data System (LI\-RADS) score of \= 2 by central radiologist evaluation.

•1\.Other causes of liver disease that are primary, secondary, or otherwise causes of cirrhosis or which may confound the intended patient population according to the investigator, 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 deficiency 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\.Prior or pending liver transplantation.
•5\.Child Pugh class B and C status.
•6\.Model of end stage liver disease (MELD) score\>12\.
•7\.Evidence of worsening liver disease (defined below) between screening visits (i.e. Day \-56 and Day \-42\) including measures of AST,ALT,ALP or TBL
•8\.History of porto\-systemic shunt procedure.
•9\.No evidence of gastroesophageal varices as documented by one of the following assessments:
•a.A historical and locally evaluated EGD obtained within 365 days of screening or