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 6, 2020

ConditionsCompensated Cirrhosis Due to Nonalcoholic Steatohepatitis MedDRA version: 22.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 20.1Level: LLTClassification code 10064844Term: Compensated cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

DrugsRosuvastatin 5 mg Film-coated Tablets

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Sponsor: GM Biopharmaceuticals, Inc.
Enrollment: 150
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 6, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GM Biopharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•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\. Total LFC \= 5% as measured by MRI\-PDFF.
•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.

Exclusion Criteria

•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, alkaline phosphatase (ALP) or total bilirubin (TBL):
•8\. History of porto\-systemic shunt procedure.
•9\. Based on screening endoscopy (EGD), has any evidence of varices regardless of size.
•10\. Clinically significant cardiovascular or cerebrovascular event or new diagnosis within 6 months of Screening, including but not limited to congestive heart failure, myocardial infarction, acute coronary syndrome, revascularization, stroke (hemorrhagic or ischemic), transient ischemic attack (TIA), or implanted defibrillator or pacemaker (for uncomplicated elective, non\-biventricular pacemaker procedure, 3 months post procedure will be allowed).