Nonalcoholic Steatohepatitis (NASH)Phase 2NCT05118360
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH
A Phase 2 study testing ASC41 2 mg and ASC41 4 mg in people with Nonalcoholic Steatohepatitis (NASH), run by Gannex Pharma Co., Ltd..
Trial summary
This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH)
- What is being tested?
- ASC41 2 mg and ASC41 4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 9 Jan 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of ≥ 8% liver fat content on screening MRI-PDFF.
- Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by NASH activity score (NAS) greater than or equal to 4 with at least 1 point each in inflammation and ballooning.
- Diabetes Mellitus well controlled based on laboratory test HbA1c ≤ 9.5%.
Who cannot join
- Evidence of advanced liver disease such as cirrhosis (stage 4 fibrosis) or decompensated liver disease (e.g. ascites, esophageal varices) or liver cancer.
- Evidence of other causes of chronic liver disease.
- Weight change ≥ 5% after qualifying liver biopsy or MRI-PDFF performed.
- Any contraindications to a MRI scan.
- Treatment with vitamin E (unless stable dose of < 400 IU/d), thiazolidinediones (TZD), or glucagon-like peptide-1 receptor agonists (GLP-1 RA), unless subject is on a stable dose for 6 months prior to qualifying liver biopsy.
- Known history of alcohol or other substance abuse within the last year or at any time during the study.
- Use of any investigational drug within 6 months of MRI-PDFF and/or liver biopsy.
- Known positivity for antibody to Human Immunodeficiency Virus (HIV).
About this study
Official title: A Seamless Phase 2a/2b, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41, a Thyroid Hormone Receptor β Agonist, in Adults With Nonalcoholic Steatohepatitis (NASH)
This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- ASC41 2 mg, ASC41 4 mg, Placebo
- Keywords
- NAFLD, Phase 2, Thyroid hormone receptor agonist, NASH, ASC41
- 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.
ASC41 2 mgDrug
2mg of ASC41 orally once daily for 52 weeks
ASC41 4 mgDrug
4mg of ASC41 orally once daily for 52 weeks
PlaceboDrug
Matching placebo orally once daily for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Part 1-ASC41 2mg | Experimental | ASC41 2mg for 52 weeks. Receives: Drug: ASC41 2 mg |
| Part1-placebo | Placebo comparator | Matching placebo for 52 weeks. Receives: Drug: Placebo |
| Part 2-ASC41 4mg | Experimental | ASC41 4 mg for 52 weeks. Receives: Drug: ASC41 4 mg |
| Part2-placebo | Placebo comparator | Matching placebo for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of ASC41 subjects compared to placebo with histological reduction in NAS ≥2 points that results from reduction of inflammation or ballooning and no worsening fibrosis assessed by histopathological reading of liver biopsy at Week 52
Measured: Baseline to Week 52
Secondary outcomes (3)
Safety and tolerability of ASC41 evaluated by incidence of treatment emergent adverse events (TEAEs) in ASC41 treated subjects compared to placebo
Measured: Baseline to Week 52
Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo.
Measured: Baseline to Week 12 and Week 52
Resolution of NASH on overall histopathological reading of liver biopsy specimen taken at Week 52 compared to baseline in ASC41 treated subjects compared to placebo treated subjects
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start1 Dec 2023 (estimated)
- Primary completion10 Nov 2024 (estimated)
- Study completion9 Jan 2025 (estimated)
Why it stopped: This study has been cancelled due to business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies 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
- Sequential
- Model description
- Randomized in 2:1 ratio to receive either oral ASC41 2 mg or oral matching placebo. Randomized in 2:1 ratio to receive either oral ASC41 4 mg or oral matching placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gannex Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118360
- Sponsor's protocol ID
- ASC41-201
- Status last verified
- Sep 2024
- First submitted
- 1 Nov 2021
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Seamless Phase 2a/2b, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41, a Thyroid Hormone Receptor β Agonist, in Adults With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT05118360
- Acronym / sponsor ID
- ASC41-201
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Keywords
- NAFLD, Phase 2, Thyroid hormone receptor agonist, NASH, ASC41
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been cancelled due to business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gannex Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 10 Nov 2024 (estimated)
- Study completion
- 9 Jan 2025 (estimated)
- First posted
- 12 Nov 2021 (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.
This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized in 2:1 ratio to receive either oral ASC41 2 mg or oral matching placebo. Randomized in 2:1 ratio to receive either oral ASC41 4 mg or oral matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Part 1-ASC41 2mg | Experimental | Drug: ASC41 2 mgASC41 2mg for 52 weeks. |
| Part1-placebo | Placebo comparator | Drug: PlaceboMatching placebo for 52 weeks. |
| Part 2-ASC41 4mg | Experimental | Drug: ASC41 4 mgASC41 4 mg for 52 weeks. |
| Part2-placebo | Placebo comparator | Drug: PlaceboMatching placebo for 52 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of ≥ 8% liver fat content on screening MRI-PDFF.
- Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by NASH activity score (NAS) greater than or equal to 4 with at least 1 point each in inflammation and ballooning.
- Diabetes Mellitus well controlled based on laboratory test HbA1c ≤ 9.5%.
Key exclusion criteria (8 listed)
- Evidence of advanced liver disease such as cirrhosis (stage 4 fibrosis) or decompensated liver disease (e.g. ascites, esophageal varices) or liver cancer.
- Evidence of other causes of chronic liver disease.
- Weight change ≥ 5% after qualifying liver biopsy or MRI-PDFF performed.
- Any contraindications to a MRI scan.
- Treatment with vitamin E (unless stable dose of < 400 IU/d), thiazolidinediones (TZD), or glucagon-like peptide-1 receptor agonists (GLP-1 RA), unless subject is on a stable dose for 6 months prior to qualifying liver biopsy.
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 |
|---|---|---|
| ASC41 2 mg2mg of ASC41 orally once daily for 52 weeks | Drug | Part 1-ASC41 2mg |
| ASC41 4 mg4mg of ASC41 orally once daily for 52 weeks | Drug | Part 2-ASC41 4mg |
| PlaceboMatching placebo orally once daily for 52 weeks. | Drug | Part1-placebo, Part2-placebo |
Primary outcome
Percent of ASC41 subjects compared to placebo with histological reduction in NAS ≥2 points that results from reduction of inflammation or ballooning and no worsening fibrosis assessed by histopathological reading of liver biopsy at Week 52
Time frame: Baseline to Week 52
3 secondary outcomes
Safety and tolerability of ASC41 evaluated by incidence of treatment emergent adverse events (TEAEs) in ASC41 treated subjects compared to placebo
Time frame: Baseline to Week 52
Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo.
Time frame: Baseline to Week 12 and Week 52
Resolution of NASH on overall histopathological reading of liver biopsy specimen taken at Week 52 compared to baseline in ASC41 treated subjects compared to placebo treated subjects
Time frame: Baseline to Week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASC41 2 mg and ASC41 4 mg in people with Nonalcoholic Steatohepatitis (NASH), run by Gannex Pharma Co., Ltd..
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 8 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: withdrawn, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percent of ASC41 subjects compared to placebo with histological reduction in NAS ≥2 points that results from reduction of inflammation or ballooning and no worsening fibrosis assessed by histopathological reading of liver biopsy at Week 52 (time frame: Baseline to Week 52). 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 27 Sep 2024.