Overview

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