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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2021-05-11

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

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Detailed Description

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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

Conditions

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Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Placebo

ALS-L1023 1,200mg

ALS-L1023 600mg twice a day

Group Type EXPERIMENTAL

ALS-L1023 1,200mg

Intervention Type DRUG

ALS-L1023

ALS-L1023 1,800mg

ALS-L1023 900mg twice a day

Group Type EXPERIMENTAL

ALS-L1023 1,800mg

Intervention Type DRUG

ALS-L1023

Interventions

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Placebo oral tablet

Placebo

Intervention Type DRUG

ALS-L1023 1,200mg

ALS-L1023

Intervention Type DRUG

ALS-L1023 1,800mg

ALS-L1023

Intervention Type DRUG

Other Intervention Names

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Placebo ALS-L1023 tablet ALS-L1023 tablet

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No