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

Primary Purpose

Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo oral tablet
ALS-L1023 1,200mg
ALS-L1023 1,800mg
Sponsored by
AngioLab, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hanyang University Seoul Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

ALS-L1023 1,200mg

ALS-L1023 1,800mg

Arm Description

Placebo

ALS-L1023 600mg twice a day

ALS-L1023 900mg twice a day

Outcomes

Primary Outcome Measures

Change in liver fat percentage measured by MRI-PDFF
Liver fat is measured by MRI-PDFF
Change in liver fibrosis measured by MRE
Liver fibrosis is measured by Magnetic Resonance Enterography
Change in visceral fat area measured by MRI
Visceral fat area is measured by MRI
Changes in serum concentrations of ALT and AST
ALT and AST concentrations in serum are measured

Secondary Outcome Measures

Change in serum concentration of Pro-C3
Pro-C3 concentration in serum is measured
Change in serum concentration of CK-18
CK-18 concentration in serum is measured
Change in insulin sensitivity determined by HOMA-IR
Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance
Change in serum concentration of Leptin
Concentration of Leptin in serum is measured
Changes in serum concentrations of ALT and AST
ALT and AST concentrations in serum are measured
Changes in serum concentrations of TG and TC
Triglyceride and Total Cholesterol concentrations in serum are measured
Change of NAFLD fibrosis score(NFS)
NFS is measured
Change in serum concentration of Ghrelin
Concentration of Ghrelin in serum is measured
Change in serum concentration of Adiponection
Concentration of Adiponection in serum is measured

Full Information

First Posted
April 6, 2020
Last Updated
August 9, 2022
Sponsor
AngioLab, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04342793
Brief Title
A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AngioLab, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
ALS-L1023 1,200mg
Arm Type
Experimental
Arm Description
ALS-L1023 600mg twice a day
Arm Title
ALS-L1023 1,800mg
Arm Type
Experimental
Arm Description
ALS-L1023 900mg twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
ALS-L1023 1,200mg
Other Intervention Name(s)
ALS-L1023 tablet
Intervention Description
ALS-L1023
Intervention Type
Drug
Intervention Name(s)
ALS-L1023 1,800mg
Other Intervention Name(s)
ALS-L1023 tablet
Intervention Description
ALS-L1023
Primary Outcome Measure Information:
Title
Change in liver fat percentage measured by MRI-PDFF
Description
Liver fat is measured by MRI-PDFF
Time Frame
baseline, 24 weeks
Title
Change in liver fibrosis measured by MRE
Description
Liver fibrosis is measured by Magnetic Resonance Enterography
Time Frame
baseline, 24 weeks
Title
Change in visceral fat area measured by MRI
Description
Visceral fat area is measured by MRI
Time Frame
baseline, 24weeks
Title
Changes in serum concentrations of ALT and AST
Description
ALT and AST concentrations in serum are measured
Time Frame
baseline, 24weeks
Secondary Outcome Measure Information:
Title
Change in serum concentration of Pro-C3
Description
Pro-C3 concentration in serum is measured
Time Frame
baseline, 24weeks
Title
Change in serum concentration of CK-18
Description
CK-18 concentration in serum is measured
Time Frame
baseline, 24weeks
Title
Change in insulin sensitivity determined by HOMA-IR
Description
Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance
Time Frame
baseline, 24weeks
Title
Change in serum concentration of Leptin
Description
Concentration of Leptin in serum is measured
Time Frame
baseline, 24weeks
Title
Changes in serum concentrations of ALT and AST
Description
ALT and AST concentrations in serum are measured
Time Frame
baseline, 8weeks, 16weeks
Title
Changes in serum concentrations of TG and TC
Description
Triglyceride and Total Cholesterol concentrations in serum are measured
Time Frame
baseline, 8weeks, 16weeks, 24weeks
Title
Change of NAFLD fibrosis score(NFS)
Description
NFS is measured
Time Frame
baseline, 8weeks, 16weeks, 24weeks
Title
Change in serum concentration of Ghrelin
Description
Concentration of Ghrelin in serum is measured
Time Frame
baseline, 24weeks
Title
Change in serum concentration of Adiponection
Description
Concentration of Adiponection in serum is measured
Time Frame
baseline, 24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Won Jun, Ph. D.
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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