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

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

Detailed Description
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Besides the main objectives, there are other objectives as follows: To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive imaging biomarker MRI-PDFF and MRE To determine optimized dose of ALS-L1023 in NASH disease

Official Title
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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)

Conditions
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Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: Placebo oral tablet
* Drug: ALS-L1023 1,200mg
* Drug: ALS-L1023 1,800mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo oral tablet<br>* Placebo<br>* Other names: Placebo;|
| Experimental: ALS-L1023 1,200mg<br>ALS-L1023 600mg twice a day | Drug: ALS-L1023 1,200mg<br>* ALS-L1023<br>* Other names: ALS-L1023 tablet;|
| Experimental: ALS-L1023 1,800mg<br>ALS-L1023 900mg twice a day | Drug: ALS-L1023 1,800mg<br>* ALS-L1023<br>* Other names: ALS-L1023 tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver fat percentage measured by MRI-PDFF | Liver fat is measured by MRI-PDFF | baseline, 24 weeks | 
| Change in liver fibrosis measured by MRE | Liver fibrosis is measured by Magnetic Resonance Enterography | baseline, 24 weeks | 
| Change in visceral fat area measured by MRI | Visceral fat area is measured by MRI | baseline, 24weeks | 
| Changes in serum concentrations of ALT and AST | ALT and AST concentrations in serum are measured | baseline, 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum concentration of Pro-C3 | Pro-C3 concentration in serum is measured | baseline, 24weeks | 
| Change in serum concentration of CK-18 | CK-18 concentration in serum is measured | baseline, 24weeks | 
| Change in insulin sensitivity determined by HOMA-IR | Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance | baseline, 24weeks | 
| Change in serum concentration of Leptin | Concentration of Leptin in serum is measured | baseline, 24weeks | 
| Changes in serum concentrations of ALT and AST | ALT and AST concentrations in serum are measured | baseline, 8weeks, 16weeks | 
| Changes in serum concentrations of TG and TC | Triglyceride and Total Cholesterol concentrations in serum are measured | baseline, 8weeks, 16weeks, 24weeks | 
| Change of NAFLD fibrosis score(NFS) | NFS is measured | baseline, 8weeks, 16weeks, 24weeks | 
| Change in serum concentration of Ghrelin | Concentration of Ghrelin in serum is measured | baseline, 24weeks | 
| Change in serum concentration of Adiponection | Concentration of Adiponection in serum is measured | baseline, 24weeks |