A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

VSA006: every 12 weeks, subcutaneous injections

Placebo: every 12 weeks, subcutaneous injections

Study 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.

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.

Eligibility

Primary outcome measure(s)

• Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH — 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 — 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.

Trial sites (1)

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