Clinical trial NCT04342793: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Lead sponsor: AngioLab, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in liver fat percentage measured by MRI-PDFF
timeFrame: baseline, 24 weeks
measure: Change in liver fibrosis measured by MRE
timeFrame: baseline, 24 weeks
measure: Change in visceral fat area measured by MRI
timeFrame: baseline, 24weeks
measure: Changes in serum concentrations of ALT and AST
timeFrame: baseline, 24weeks
Secondary outcomes:
measure: Change in serum concentration of Pro-C3
timeFrame: baseline, 24weeks
measure: Change in serum concentration of CK-18
timeFrame: baseline, 24weeks
measure: Change in insulin sensitivity determined by HOMA-IR
timeFrame: baseline, 24weeks
measure: Change in serum concentration of Leptin
timeFrame: baseline, 24weeks
measure: Changes in serum concentrations of ALT and AST
timeFrame: baseline, 8weeks, 16weeks
measure: Changes in serum concentrations of TG and TC
timeFrame: baseline, 8weeks, 16weeks, 24weeks
measure: Change of NAFLD fibrosis score(NFS)
timeFrame: baseline, 8weeks, 16weeks, 24weeks
measure: Change in serum concentration of Ghrelin
timeFrame: baseline, 24weeks
measure: Change in serum concentration of Adiponection
timeFrame: baseline, 24weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
affiliation: Hanyang University
name: Dae Won Jun, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: