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

Phase 2

Completed

• Conditions: Nonalcoholic Steatohepatitis
• Interventions: Drug: Placebo oral tablet; Drug: ALS-L1023 1,200mg; Drug: ALS-L1023 1,800mg

• Registration Number: NCT04342793
• Lead Sponsor: 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

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 Timeline

• Study Start: 2019-12-04
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-13
• Primary Completion: 2021-05-11
• Study Completion: 2021-05-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral tablet	Placebo
ALS-L1023 1,200mg	ALS-L1023 1,200mg	ALS-L1023 600mg twice a day
ALS-L1023 1,800mg	ALS-L1023 1,800mg	ALS-L1023 900mg twice a day

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of