Nonalcoholic SteatohepatitisPhase 2NCT04342793
A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH
A Phase 2 study testing ALS-L1023 1,200mg and ALS-L1023 1,800mg in people with Nonalcoholic Steatohepatitis, run by AngioLab, Inc. at 1 site in South Korea.
Trial summary
The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- ALS-L1023 1,200mg and ALS-L1023 1,800mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Dec 2019to 11 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis
Read the detailed description
Besides the main objectives, there are other objectives as follows:
- To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive imaging biomarker MRI-PDFF and MRE
- To determine optimized dose of ALS-L1023 in NASH disease
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- Placebo oral tablet, ALS-L1023 1,200mg, ALS-L1023 1,800mg
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral tabletDrug
Also called Placebo
Placebo
ALS-L1023 1,200mgDrug
Also called ALS-L1023 tablet
ALS-L1023
ALS-L1023 1,800mgDrug
Also called ALS-L1023 tablet
ALS-L1023
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo oral tablet |
| ALS-L1023 1,200mg | Experimental | ALS-L1023 600mg twice a day Receives: Drug: ALS-L1023 1,200mg |
| ALS-L1023 1,800mg | Experimental | ALS-L1023 900mg twice a day Receives: Drug: ALS-L1023 1,800mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver fat percentage measured by MRI-PDFF
Liver fat is measured by MRI-PDFF
Measured: baseline, 24 weeks
Change in liver fibrosis measured by MRE
Liver fibrosis is measured by Magnetic Resonance Enterography
Measured: baseline, 24 weeks
Change in visceral fat area measured by MRI
Visceral fat area is measured by MRI
Measured: baseline, 24weeks
Changes in serum concentrations of ALT and AST
ALT and AST concentrations in serum are measured
Measured: baseline, 24weeks
Secondary outcomes (9)
Change in serum concentration of Pro-C3
Pro-C3 concentration in serum is measured
Measured: baseline, 24weeks
Change in serum concentration of CK-18
CK-18 concentration in serum is measured
Measured: baseline, 24weeks
Change in insulin sensitivity determined by HOMA-IR
Insulin sensitivity is determined by Homeostatic Model Assessment for Insulin Resistance
Measured: baseline, 24weeks
Change in serum concentration of Leptin
Concentration of Leptin in serum is measured
Measured: baseline, 24weeks
Changes in serum concentrations of ALT and AST
ALT and AST concentrations in serum are measured
Measured: baseline, 8weeks, 16weeks
Changes in serum concentrations of TG and TC
Triglyceride and Total Cholesterol concentrations in serum are measured
Measured: baseline, 8weeks, 16weeks, 24weeks
Change of NAFLD fibrosis score(NFS)
NFS is measured
Measured: baseline, 8weeks, 16weeks, 24weeks
Change in serum concentration of Ghrelin
Concentration of Ghrelin in serum is measured
Measured: baseline, 24weeks
Change in serum concentration of Adiponection
Concentration of Adiponection in serum is measured
Measured: baseline, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start4 Dec 2019
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AngioLab, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dae Won Jun, Ph. D., Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342793
- Sponsor's protocol ID
- AL101-NASH
- Status last verified
- Aug 2022
- First submitted
- 6 Apr 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04342793
- Acronym / sponsor ID
- AL101-NASH
- Conditions
- Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AngioLab, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate efficacy of ALS-L1023 for liver fibrosis and steatosis by noninvasive imaging biomarker MRI-PDFF and MRE
- To determine optimized dose of ALS-L1023 in NASH disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo |
| ALS-L1023 1,200mg | Experimental | Drug: ALS-L1023 1,200mgALS-L1023 600mg twice a day |
| ALS-L1023 1,800mg | Experimental | Drug: ALS-L1023 1,800mgALS-L1023 900mg twice a day |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo oral tabletAlso: PlaceboPlacebo | Drug | Placebo |
| ALS-L1023 1,200mgAlso: ALS-L1023 tabletALS-L1023 | Drug | ALS-L1023 1,200mg |
| ALS-L1023 1,800mgAlso: ALS-L1023 tabletALS-L1023 | Drug | ALS-L1023 1,800mg |
Primary outcome
Change in liver fat percentage measured by MRI-PDFF
Time frame: baseline, 24 weeks
Liver fat is measured by MRI-PDFF
Change in liver fibrosis measured by MRE
Time frame: baseline, 24 weeks
Liver fibrosis is measured by Magnetic Resonance Enterography
Change in visceral fat area measured by MRI
Time frame: baseline, 24weeks
Visceral fat area is measured by MRI
Changes in serum concentrations of ALT and AST
Time frame: baseline, 24weeks
ALT and AST concentrations in serum are measured
9 secondary outcomes
Change in serum concentration of Pro-C3
Time frame: baseline, 24weeks
Change in serum concentration of CK-18
Time frame: baseline, 24weeks
Change in insulin sensitivity determined by HOMA-IR
Time frame: baseline, 24weeks
Change in serum concentration of Leptin
Time frame: baseline, 24weeks
Changes in serum concentrations of ALT and AST
Time frame: baseline, 8weeks, 16weeks
Changes in serum concentrations of TG and TC
Time frame: baseline, 8weeks, 16weeks, 24weeks
Change of NAFLD fibrosis score(NFS)
Time frame: baseline, 8weeks, 16weeks, 24weeks
Change in serum concentration of Ghrelin
Time frame: baseline, 24weeks
Change in serum concentration of Adiponection
Time frame: baseline, 24weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae Won Jun, Ph. D. principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALS-L1023 1,200mg and ALS-L1023 1,800mg in people with Nonalcoholic Steatohepatitis, run by AngioLab, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver fat percentage measured by MRI-PDFF (time frame: baseline, 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.