Non-alcoholic Fatty Liver DiseasePhase 2NCT05462353
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
A Phase 2 study testing 2mg of ASC41 and 4mg of ASC41 (2 tablets of 2 mg ASC41) in people with Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Gannex Pharma Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
- What is being tested?
- 2mg of ASC41 and 4mg of ASC41 (2 tablets of 2 mg ASC41)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 10 Jun 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
- Age ≥ 18 and ≤ 80 years old at screening.
- Presence of ≥ 7.5% steatosis on screening MRI-PDFF read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit.
- HbA1c ≤ 9.5%.
- Normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m^2
Who cannot join
- Presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma.
- History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings.
- Uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c of > 9.5% within 60 days prior to enrollment.
- Change in anti-diabetic therapy within 6 months prior to qualifying liver biopsy.
Trial locations and contacts
1 site in 1 country.
China1 site
The affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310000
About this study
Official title: A Phase II, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Subjects With Nonalcoholic Steatohepatitis (NASH)
This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).
- Being tested
- 2mg of ASC41, 4mg of ASC41 (2 tablets of 2 mg ASC41), Placebo
- Keywords
- Non-alcoholic Fatty Liver Disease, NASH, ASC41, Phase II, THR-β
- 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.
2mg of ASC41Drug
ASC41 tablet administered orally once daily.
4mg of ASC41 (2 tablets of 2 mg ASC41)Drug
ASC41 tablets administered orally once daily.
PlaceboDrug
Placebo tablets administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Low Dose | Experimental | 1 tablet of ASC41 (2 mg) for 52 weeks Receives: Drug: 2mg of ASC41; Drug: Placebo |
| Cohort 2 High Dose | Experimental | 2 tablet of ASC41 (4 mg) for 52 weeks Receives: Drug: 4mg of ASC41 (2 tablets of 2 mg ASC41) |
| Placebo tablet | Placebo comparator | Placebo tablet for 52 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.
A histological change in NAFLD (nonalcoholic fatty liver disease) Activity Score (NAS) ≥ 2 points that results from reduction of necroinflammation (inflammation or ballooning) without worsening fibrosis. (The NAFLD Activity Score including steatosis, inflammation and ballooning. The maximum score of steatosis was 3 and the minimum score was 0, the maximum score of inflammation was 3 and the minimum score was 0, and the maximum score of ballooning was 2 and the minimum score was 0. The higher scores mean a worse outcome. ）
Measured: Baseline and Week 52
Secondary outcomes (6)
The incidence, type and severity of AEs/SAEs were assessed by CTCAE v5.0 to assess the safety and tolerability of ASC41 compared to placebo
Measured: 24 and 52 weeks
Change from baseline in hepatic fat fraction assessed by MRI-PDFF
Measured: 24 and 52 weeks
To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL)
Measured: 12, 24 and 52 weeks
Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)
Measured after administration
Measured: 1 and 15 Days
Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞)
Measured: 1 and 15 Days
Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)
Measured: 1 and 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start30 Sep 2022
- Primary completion10 May 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 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
- NCT05462353
- Sponsor's protocol ID
- ASC41-202
- Status last verified
- Oct 2024
- First submitted
- 7 Jul 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Subjects With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT05462353
- Acronym / sponsor ID
- ASC41-202
- Keywords
- Non-alcoholic Fatty Liver Disease, NASH, ASC41, Phase II, THR-β
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Gannex Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 18 Jul 2022 (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, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Low Dose | Experimental | Drug: 2mg of ASC41, Drug: Placebo1 tablet of ASC41 (2 mg) for 52 weeks |
| Cohort 2 High Dose | Experimental | Drug: 4mg of ASC41 (2 tablets of 2 mg ASC41)2 tablet of ASC41 (4 mg) for 52 weeks |
| Placebo tablet | Placebo comparator | Drug: PlaceboPlacebo tablet 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 (4 listed)
- Age ≥ 18 and ≤ 80 years old at screening.
- Presence of ≥ 7.5% steatosis on screening MRI-PDFF read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit.
- HbA1c ≤ 9.5%.
- Normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m^2
Key exclusion criteria (4 listed)
- Presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma.
- History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings.
- Uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c of > 9.5% within 60 days prior to enrollment.
- Change in anti-diabetic therapy within 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 |
|---|---|---|
| 2mg of ASC41ASC41 tablet administered orally once daily. | Drug | Cohort 1 Low Dose |
| 4mg of ASC41 (2 tablets of 2 mg ASC41)ASC41 tablets administered orally once daily. | Drug | Cohort 2 High Dose |
| PlaceboPlacebo tablets administered orally once daily. | Drug | Cohort 1 Low Dose, Placebo tablet |
Primary outcome
To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.
Time frame: Baseline and Week 52
A histological change in NAFLD (nonalcoholic fatty liver disease) Activity Score (NAS) ≥ 2 points that results from reduction of necroinflammation (inflammation or ballooning) without worsening fibrosis. (The NAFLD Activity Score including steatosis, inflammation and ballooning. The maximum score of steatosis was 3 and the minimum score was 0, the maximum score of inflammation was 3 and the minimum score was 0, and the maximum score of ballooning was 2 and the minimum score was 0. The higher scores mean a worse outcome. ）
6 secondary outcomes
The incidence, type and severity of AEs/SAEs were assessed by CTCAE v5.0 to assess the safety and tolerability of ASC41 compared to placebo
Time frame: 24 and 52 weeks
Change from baseline in hepatic fat fraction assessed by MRI-PDFF
Time frame: 24 and 52 weeks
To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL)
Time frame: 12, 24 and 52 weeks
Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)
Time frame: 1 and 15 Days
Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞)
Time frame: 1 and 15 Days
Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)
Time frame: 1 and 15 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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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.
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 2mg of ASC41 and 4mg of ASC41 (2 tablets of 2 mg ASC41) in people with Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Gannex Pharma Co., Ltd. at 1 site in China.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Jan 2025. 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 China. 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?
Results are not available in the source record.
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?
To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change. (time frame: Baseline and 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 8 Jan 2025.