Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH
Lead Sponsor:
AngioLab, Inc.
Conditions:
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
19-75 years
Phase:
PHASE2
Brief Summary
The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis
Detailed Description
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 deter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04342793
Start Date
December 4 2019
End Date
May 11 2021
Last Update
August 11 2022
Active Locations (1)
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1
Hanyang University Seoul Hospital
Seoul, South Korea, 04763