drugset / Trial / NCT06322628

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

NCT06322628 ↗

Phase 2 Active not recruiting 48 enrolled Visirna Therapeutics HK Limited
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-04-22
Primary completion
2026-07
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject VSA006 Small interfering RNA (siRNA) — Subcutaneous