Nonalcoholic Steatohepatitis
Conditions
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 determine optimized dose of ALS-L1023 in NASH disease
Interventions
DRUGPlacebo oral tablet
Placebo
DRUGALS-L1023 1,200mg
ALS-L1023
DRUGALS-L1023 1,800mg
ALS-L1023
Sponsors
AngioLab, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum concentrations of ALT and AST | baseline, 24weeks | ALT and AST concentrations in serum are measured |
| Change in liver fibrosis measured by MRE | baseline, 24 weeks | Liver fibrosis is measured by Magnetic Resonance Enterography |
| Change in visceral fat area measured by MRI | baseline, 24weeks | Visceral fat area is measured by MRI |
| Change in liver fat percentage measured by MRI-PDFF | baseline, 24 weeks | Liver fat is measured by MRI-PDFF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum concentrations of ALT and AST | baseline, 8weeks, 16weeks | ALT and AST concentrations in serum are measured |
| Changes in serum concentrations of TG and TC | baseline, 8weeks, 16weeks, 24weeks | Triglyceride and Total Cholesterol concentrations in serum are measured |
| Change in serum concentration of Pro-C3 | baseline, 24weeks | Pro-C3 concentration in serum is measured |
| Change in serum concentration of Ghrelin | baseline, 24weeks | Concentration of Ghrelin in serum is measured |
| Change in serum concentration of Adiponection | baseline, 24weeks | Concentration of Adiponection in serum is measured |
| Change of NAFLD fibrosis score(NFS) | baseline, 8weeks, 16weeks, 24weeks | NFS is measured |
| Change in serum concentration of CK-18 | baseline, 24weeks | CK-18 concentration in serum is measured |
| Change in insulin sensitivity determined by HOMA-IR | baseline, 24weeks | Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance |
| Change in serum concentration of Leptin | baseline, 24weeks | Concentration of Leptin in serum is measured |
Countries
South Korea
Outcome results
None listed