Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)
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Lead
NGM Biopharmaceuticals, Inc
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Histologically confirmed NASH diagnosis as defined by the NASH CRN
2. Total liver fat content of ≥ 8% as measured by MRI-PDFF
You may not be if
1. Clinically significant acute or chronic liver disease of an etiology other than NASH
2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis
3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters
4. Prior or pending liver transplantation
Clareo Health | Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)