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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342793
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
AngioLab, Inc.

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

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: Placebo oral tablet Drug: ALS-L1023 1,200mg Drug: ALS-L1023 1,800mg Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : December 4, 2020
Estimated Study Completion Date : December 4, 2020


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo oral tablet
Placebo
Other Name: Placebo

Experimental: ALS-L1023 1,200mg
ALS-L1023 600mg twice a day
Drug: ALS-L1023 1,200mg
ALS-L1023
Other Name: ALS-L1023 tablet

Experimental: ALS-L1023 1,800mg
ALS-L1023 900mg twice a day
Drug: ALS-L1023 1,800mg
ALS-L1023
Other Name: ALS-L1023 tablet




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342793


Contacts
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Contact: Min-Young Kim +82-42-867-5785 angiolab@angiolab.co.kr

Locations
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Korea, Republic of
Hanyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of, 04763
Contact: Dae Won Jun    +82-02-2290-8338    noshin@hanyang.ac.kr   
Sponsors and Collaborators
AngioLab, Inc.
Investigators
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Principal Investigator: Dae Won Jun, Ph. D. Hanyang University
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Responsible Party: AngioLab, Inc.
ClinicalTrials.gov Identifier: NCT04342793    
Other Study ID Numbers: AL101-NASH
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases