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Completed

NCT Number: NCT04342793

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

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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Key information

Conditions

Nonalcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo oral tablet

Drug

Placebo

Other names: Placebo

ALS-L1023 1,200mg

Drug

ALS-L1023

Other names: ALS-L1023 tablet

ALS-L1023 1,800mg

Drug

ALS-L1023

Other names: ALS-L1023 tablet

Primary outcomes

  1. Change in liver fat percentage measured by MRI-PDFF

    Time frame: baseline, 24 weeks

    Liver fat is measured by MRI-PDFF

  2. Change in liver fibrosis measured by MRE

    Time frame: baseline, 24 weeks

    Liver fibrosis is measured by Magnetic Resonance Enterography

  3. Change in visceral fat area measured by MRI

    Time frame: baseline, 24weeks

    Visceral fat area is measured by MRI

  4. Changes in serum concentrations of ALT and AST

    Time frame: baseline, 24weeks

    ALT and AST concentrations in serum are measured

Secondary outcomes

  1. Change in serum concentration of Pro-C3

    Time frame: baseline, 24weeks

    Pro-C3 concentration in serum is measured

  2. Change in serum concentration of CK-18

    Time frame: baseline, 24weeks

    CK-18 concentration in serum is measured

  3. Change in insulin sensitivity determined by HOMA-IR

    Time frame: baseline, 24weeks

    Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance

  4. Change in serum concentration of Leptin

    Time frame: baseline, 24weeks

    Concentration of Leptin in serum is measured

  5. Changes in serum concentrations of ALT and AST

    Time frame: baseline, 8weeks, 16weeks

    ALT and AST concentrations in serum are measured

  6. Changes in serum concentrations of TG and TC

    Time frame: baseline, 8weeks, 16weeks, 24weeks

    Triglyceride and Total Cholesterol concentrations in serum are measured

  7. Change of NAFLD fibrosis score(NFS)

    Time frame: baseline, 8weeks, 16weeks, 24weeks

    NFS is measured

  8. Change in serum concentration of Ghrelin

    Time frame: baseline, 24weeks

    Concentration of Ghrelin in serum is measured

  9. Change in serum concentration of Adiponection

    Time frame: baseline, 24weeks

    Concentration of Adiponection in serum is measured

Sponsors and collaborators

Lead sponsor

AngioLab, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2020
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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