A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Study to Explore the Safety and Efficacy of ALS-L1023 in Patients With Non-alcoholic Steatohepatitis (NASH)

The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis

Besides the main objectives, there are other objectives as follows:

1. To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive imaging biomarker MRI-PDFF and MRE
2. To determine optimized dose of ALS-L1023 in NASH disease

Inclusion Criteria:

• Men or women ages 19 and over, under 75 years of age
• Patients diagnosed with NAFLD on abdominal ultrasonography and MRI
• Patients show presence of hepatic fat fraction as defined by ≥ 8% on MRI-PDFF and liver stiffness as defined by ≥ 2.5 kPa on MRE at Screening

Exclusion Criteria:

• Any subject with current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 2 year prior to screening will be excluded
• Chronic liver disease (including hemochromatosis, liver cancer, autoimmune liver disease, viral hepatitis A, B, alcoholic liver disease
• Uncontrolled diabetes mellitus as defined by a HbA1c ≥ 9.0％ at Screening
• Patients who are allergic or hypersensitive to the drug or its constituents
• Pregnant or lactating women