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

AngioLab

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Steatohepatitis

Treatments: Drug: Placebo oral tablet; Drug: ALS-L1023 1,800mg; Drug: ALS-L1023 1,200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04342793

AL101-NASH

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo oral tablet

ALS-L1023 1,200mg

Experimental group

Description:

ALS-L1023 600mg twice a day

Treatment:

Drug: ALS-L1023 1,200mg

ALS-L1023 1,800mg

Experimental group

Description:

ALS-L1023 900mg twice a day

Treatment:

Drug: ALS-L1023 1,800mg