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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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;
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)
Facility
City
Region
Status
Beijing Tsinghua Changgeng Hospital
Beijing
Beijing Municipality
More Visirna Therapeutics HK Limited trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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