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

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AngioLab, Inc.

Criteria

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