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) | NYU Langone Health

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)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Non-alcoholic Steatohepatitis (nash)
Age: Between 18 years - 75 years
Gender: Male or Female

Other Inclusion Criteria:
1. Males and females between 18 and 75 years of age, who are able to comprehend and provide a written informed consent
2. Liver biopsy consistent with a diagnosis of NASH and Fibrosis Stage 4 (F4) Cirrhosis
3. Negative for hepatic lesions/nodules indicating HCC risk
4. Female subjects must have negative pregnancy test and agree to use contraceptive methods as per the protocol
5. Able and willing to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

You may not be eligible for this study if the following are true:

1. Other causes of liver disease that are primary, secondary, or otherwise causes of cirrhosis
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
4. Prior or pending liver transplantation
5. Child Pugh class B or class C statu
6. Model of end stage liver disease (MELD) score > 12
7. Evidence of worsening liver disease
8. History of porto-systemic shunt procedure
9. Clinically significant cardiovascular or cerebrovascular event or new diagnosis
10. Gastric bypass or bariatric surgery
11. History of clinically significant unstable or untreated illness or any other major medical disorder
12. Documented significant weight change (± 5%) < 3 months
13. Screening ECG with clinically significant abnormalities
14. Positive for HBsAg, antiHIV Ab, or antiHCV Ab plus HCV-RNA
15. History of malignancy
16. A positive drug screen
17. Significant alcohol intake
18. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject’s ability to participate, complete, and/or would confound data interpretation in this clinical study.