A Phase 2 interventional study of VSA006 and Placebo in Nash, sponsored by Visirna Therapeutics HK Limited. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Visirna Therapeutics HK Limited · Phase 2, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Visirna Therapeutics HK Limited is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: VSA006
Drug: Placebo
Drug: VSA006
Drug: Placebo
every 12 weeks, subcutaneous injections
every 12 weeks, subcutaneous injections
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.
Time frame: 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.
Time frame: At week 52
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
measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)
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
measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)
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
NASH resolution was defined as a NAS score of 0-1 for inflammation, 0 for ballooning, and no increase in steatosis score
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
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease→
Visirna Therapeutics HK Limited