Phase 2Active, not recruiting
A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients
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)
- Sponsor
- Visirna Therapeutics HK Limited (Industry)
- Enrollment
- 48 enrolled
- Conditions
- Nash
- Interventions
- VSA006; Placebo
- Ages
- adults, older adults
- Registry
- NCT06322628
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH
- Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis
History
Study completion expected
Primary completion
Last registry update
Started
Registered