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)
1 other identifier
interventional
60
1 country
1
Brief Summary
The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2019
CompletedFirst Submitted
Initial submission to the registry
April 6, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2021
CompletedAugust 11, 2022
August 1, 2022
1.4 years
April 6, 2020
August 9, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (9)
Change in serum concentration of Pro-C3
baseline, 24weeks
Change in serum concentration of CK-18
baseline, 24weeks
Change in insulin sensitivity determined by HOMA-IR
baseline, 24weeks
Change in serum concentration of Leptin
baseline, 24weeks
Changes in serum concentrations of ALT and AST
baseline, 8weeks, 16weeks
- +4 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo
ALS-L1023 1,200mg
EXPERIMENTALALS-L1023 600mg twice a day
ALS-L1023 1,800mg
EXPERIMENTALALS-L1023 900mg twice a day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AngioLab, Inc.lead
Study Sites (1)
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dae Won Jun, Ph. D.
Hanyang University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2020
First Posted
April 13, 2020
Study Start
December 4, 2019
Primary Completion
May 11, 2021
Study Completion
May 11, 2021
Last Updated
August 11, 2022
Record last verified: 2022-08