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

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)

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

Study Overview

• Status: Completed
• Conditions: Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: Placebo oral tablet; Drug: ALS-L1023 1,200mg; Drug: ALS-L1023 1,800mg

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Seoul Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo oral tablet; Placebo; Other Names: Placebo
Experimental: ALS-L1023 1,200mg; ALS-L1023 600mg twice a day	Drug: ALS-L1023 1,200mg; ALS-L1023; Other Names: ALS-L1023 tablet
Experimental: ALS-L1023 1,800mg; ALS-L1023 900mg twice a day	Drug: ALS-L1023 1,800mg; ALS-L1023; Other Names: ALS-L1023 tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in liver fat percentage measured by MRI-PDFF	Liver fat is measured by MRI-PDFF	baseline, 24 weeks
Change in liver fibrosis measured by MRE	Liver fibrosis is measured by Magnetic Resonance Enterography	baseline, 24 weeks
Change in visceral fat area measured by MRI	Visceral fat area is measured by MRI	baseline, 24weeks
Changes in serum concentrations of ALT and AST	ALT and AST concentrations in serum are measured	baseline, 24weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum concentration of Pro-C3	Pro-C3 concentration in serum is measured	baseline, 24weeks
Change in serum concentration of CK-18	CK-18 concentration in serum is measured	baseline, 24weeks
Change in insulin sensitivity determined by HOMA-IR	Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance	baseline, 24weeks
Change in serum concentration of Leptin	Concentration of Leptin in serum is measured	baseline, 24weeks
Changes in serum concentrations of ALT and AST	ALT and AST concentrations in serum are measured	baseline, 8weeks, 16weeks
Changes in serum concentrations of TG and TC	Triglyceride and Total Cholesterol concentrations in serum are measured	baseline, 8weeks, 16weeks, 24weeks
Change of NAFLD fibrosis score(NFS)	NFS is measured	baseline, 8weeks, 16weeks, 24weeks
Change in serum concentration of Ghrelin	Concentration of Ghrelin in serum is measured	baseline, 24weeks
Change in serum concentration of Adiponection	Concentration of Adiponection in serum is measured	baseline, 24weeks

Collaborators and Investigators

• Sponsor: AngioLab, Inc.
• Investigators: Principal Investigator: Dae Won Jun, Ph. D., Hanyang University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): May 11, 2021

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: AL101-NASH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No