NashPhase 2NCT06322628
A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients
A Phase 2 study testing VSA006 in people with Nash, run by Visirna Therapeutics HK Limited at 1 site in China.
Trial summary
Human genetic studies have shown that loss of function (LOF) mutations in HSD17β13 gene have a protective effect on the progression of alcohol-related and non-alcohol-related liver diseases, such as NASH, without significant adverse phenotypes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nash
- What is being tested?
- VSA006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index (BMI) of 24-35 kg/m2 ;
- NASH patients confirmed by liver histopathology: NAS score is ≥ 4 and CRN fibrosis is F2 or F3 ;
- At screening, ALT is > ULN;
- At screening, the liver fat content measured by MRI-PDFF is ≥ 8%;
- Weight change < 5% at least 3 months prior to screening;
- For patient with T2DM, the hypoglycemic agents and HbA1c is stable
Who cannot join
- Pregnant or lactating women;
- Previous diagnosis of alcoholic liver disease or hepatitis/liver disease due to other causes;
- Previous or current diagnosis of cirrhosis or decompensated cirrhosis;
- Previous or current diagnosis of hyperthyroidism, hypothyroidism, or other diseases that can lead to fatty degeneration of liver;
- Participants diagnosed with type 1 diabetes, or with unstable type 2 diabetes
- Participants who cannot receive an MRI examination;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of VSA006 Injection in Chinese Adult Patients With Nonalcoholic Steatohepatitis (NASH)
Human genetic studies have shown that loss of function (LOF) mutations in HSD17β13 gene have a protective effect on the progression of alcohol-related and non-alcohol-related liver diseases, such as NASH, without significant adverse phenotypes.
VSA006 is a siRNA drug targeting HSD17β13 mRNA in the liver and reduce the protein level of HSD17β13. Based on phase 1 study results in healthy volunteers and NASH/suspected NASH patients, this phase 2 study is designed to evaluate the efficacy, safety, PK profiles and immunogenicity of VSA006 in Chinese NASH patients.
- Conditions
- Nash
- Being tested
- VSA006, Placebo
- Keywords
- efficacy, safety, HSD17β13
- 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.
VSA006Drug
every 12 weeks, subcutaneous injections
PlaceboDrug
every 12 weeks, subcutaneous injections
| Study group | Role | What they receive |
|---|---|---|
| VSA006 low dose | Experimental | Not described Receives: Drug: VSA006 |
| VSA006 low dose comparator | Placebo comparator | Not described Receives: Drug: Placebo |
| VSA006 high dose | Experimental | Not described Receives: Drug: VSA006 |
| VSA006 high dose comparator | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH
No Worsening of NASH is defined as no increase in inflammation, ballooning, or steatosis scores in the NAS score.
Measured: At week 52
Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis
NASH Improvement indicates a reduction by at least 2 points in the NAS score, with at least one-point reduction in ballooning without increase in steatosis score.
Measured: At week 52
Secondary outcomes (10)
Compared with placebo, the percentage change in serum alanine aminotransferase (ALT)
Measured: At week 24, week 52 and week 82
Compared with placebo, the change in liver fat fraction from baseline and liver fat percentage change from baseline
measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)
Measured: At week 24 and week 52
Compared with placebo, the percentage of participants with a > 30% decrease in liver fat fraction from baseline
measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)
Measured: At week 24 and week 52
Compared with placebo, the change and percentage change in noninvasive markers of fibrosis from baseline: FIB-4, NAFLD fibrosis score, and AST/PLT ratio index (APRI)
Measured: At week 24, week 52 and week 82
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis
NASH resolution was defined as a NAS score of 0-1 for inflammation, 0 for ballooning, and no increase in steatosis score
Measured: At week 52
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their correlation with VSA006
Measured: Up to week 82
Maximum observed concentration (Cmax) of VSA006
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Time of maximum concentration of VSA006 (Tmax)
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA006
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
anti-drug antibodies (ADAs) of VSA006
Measured: up to week 82
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start22 Apr 2024
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NashStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visirna Therapeutics HK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322628
- Sponsor's protocol ID
- VSA006-2001
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of VSA006 Injection in Chinese Adult Patients With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT06322628
- Acronym / sponsor ID
- VSA006-2001
- Conditions
- Nash
- Keywords
- efficacy, safety, HSD17β13
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Visirna Therapeutics HK LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Mar 2024 (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.
Human genetic studies have shown that loss of function (LOF) mutations in HSD17β13 gene have a protective effect on the progression of alcohol-related and non-alcohol-related liver diseases, such as NASH, without significant adverse phenotypes.
VSA006 is a siRNA drug targeting HSD17β13 mRNA in the liver and reduce the protein level of HSD17β13. Based on phase 1 study results in healthy volunteers and NASH/suspected NASH patients, this phase 2 study is designed to evaluate the efficacy, safety, PK profiles and immunogenicity of VSA006 in Chinese NASH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VSA006 low dose | Experimental | Drug: VSA006 |
| VSA006 low dose comparator | Placebo comparator | Drug: Placebo |
| VSA006 high dose | Experimental | Drug: VSA006 |
| VSA006 high dose comparator | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- body mass index (BMI) of 24-35 kg/m2 ;
- NASH patients confirmed by liver histopathology: NAS score is ≥ 4 and CRN fibrosis is F2 or F3 ;
- At screening, ALT is > ULN;
- At screening, the liver fat content measured by MRI-PDFF is ≥ 8%;
- Weight change < 5% at least 3 months prior to screening;
Key exclusion criteria (6 listed)
- Pregnant or lactating women;
- Previous diagnosis of alcoholic liver disease or hepatitis/liver disease due to other causes;
- Previous or current diagnosis of cirrhosis or decompensated cirrhosis;
- Previous or current diagnosis of hyperthyroidism, hypothyroidism, or other diseases that can lead to fatty degeneration of liver;
- Participants diagnosed with type 1 diabetes, or with unstable type 2 diabetes
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 |
|---|---|---|
| VSA006every 12 weeks, subcutaneous injections | Drug | VSA006 high dose, VSA006 low dose |
| Placeboevery 12 weeks, subcutaneous injections | Drug | VSA006 high dose comparator, VSA006 low dose comparator |
Primary outcome
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH
Time frame: At week 52
No Worsening of NASH is defined as no increase in inflammation, ballooning, or steatosis scores in the NAS score.
Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis
Time frame: At week 52
NASH Improvement indicates a reduction by at least 2 points in the NAS score, with at least one-point reduction in ballooning without increase in steatosis score.
10 secondary outcomes
Compared with placebo, the percentage change in serum alanine aminotransferase (ALT)
Time frame: At week 24, week 52 and week 82
Compared with placebo, the change in liver fat fraction from baseline and liver fat percentage change from baseline
Time frame: At week 24 and week 52
Compared with placebo, the percentage of participants with a > 30% decrease in liver fat fraction from baseline
Time frame: At week 24 and week 52
Compared with placebo, the change and percentage change in noninvasive markers of fibrosis from baseline: FIB-4, NAFLD fibrosis score, and AST/PLT ratio index (APRI)
Time frame: At week 24, week 52 and week 82
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis
Time frame: At week 52
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their correlation with VSA006
Time frame: Up to week 82
Maximum observed concentration (Cmax) of VSA006
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Time of maximum concentration of VSA006 (Tmax)
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA006
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
anti-drug antibodies (ADAs) of VSA006
Time frame: up to week 82
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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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 VSA006 in people with Nash, run by Visirna Therapeutics HK Limited 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH (time frame: At week 52). The study lists 2 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 12 Mar 2026.