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

Launched by VISIRNA THERAPEUTICS HK LIMITED · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VSA006 for patients with non-alcoholic steatohepatitis (NASH), a liver condition that can lead to serious health problems. VSA006 works by targeting a specific gene in the liver to help reduce the progression of liver disease. The trial aims to determine how effective and safe this treatment is for Chinese patients diagnosed with NASH.

To participate, individuals need to be between the ages of 18 and 70, have a body mass index (BMI) between 24 and 35, and have been confirmed to have NASH based on liver tissue analysis. Additionally, they must meet certain health criteria, such as having high liver enzyme levels and a specific amount of fat in the liver. Participants will receive the treatment and will be monitored for any side effects and how well the drug works. It's important to note that this trial is not yet recruiting participants, and certain individuals, like pregnant women or those with specific other health conditions, will not be eligible to join.

Gender

ALL

Eligibility criteria

• 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;