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

Nonalcoholic Steatohepatitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342793
• Other study ID #: AL101-NASH
• Status: Completed
• Phase: Phase 2
• Start date: December 4, 2019
• Est. completion date: May 11, 2021

Study information

• Verified date: August 2022
• Source: AngioLab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 11, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• Placebo oral tablet
Placebo
• ALS-L1023 1,200mg
ALS-L1023
• ALS-L1023 1,800mg
ALS-L1023

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AngioLab, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in liver fat percentage measured by MRI-PDFF	Liver fat is measured by MRI-PDFF	baseline, 24 weeks
Primary	Change in liver fibrosis measured by MRE	Liver fibrosis is measured by Magnetic Resonance Enterography	baseline, 24 weeks
Primary	Change in visceral fat area measured by MRI	Visceral fat area is measured by MRI	baseline, 24weeks
Primary	Changes in serum concentrations of ALT and AST	ALT and AST concentrations in serum are measured	baseline, 24weeks
Secondary	Change in serum concentration of Pro-C3	Pro-C3 concentration in serum is measured	baseline, 24weeks
Secondary	Change in serum concentration of CK-18	CK-18 concentration in serum is measured	baseline, 24weeks
Secondary	Change in insulin sensitivity determined by HOMA-IR	Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance	baseline, 24weeks
Secondary	Change in serum concentration of Leptin	Concentration of Leptin in serum is measured	baseline, 24weeks
Secondary	Changes in serum concentrations of ALT and AST	ALT and AST concentrations in serum are measured	baseline, 8weeks, 16weeks
Secondary	Changes in serum concentrations of TG and TC	Triglyceride and Total Cholesterol concentrations in serum are measured	baseline, 8weeks, 16weeks, 24weeks
Secondary	Change of NAFLD fibrosis score(NFS)	NFS is measured	baseline, 8weeks, 16weeks, 24weeks
Secondary	Change in serum concentration of Ghrelin	Concentration of Ghrelin in serum is measured	baseline, 24weeks
Secondary	Change in serum concentration of Adiponection	Concentration of Adiponection in serum is measured	baseline, 24weeks