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NCT Number: NCT06322628

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

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.

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Key information

Conditions

NASH Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tsinghua Changgeng Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

VSA006

Drug

every 12 weeks, subcutaneous injections

Placebo

Drug

every 12 weeks, subcutaneous injections

Primary outcomes

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

    Time frame: At week 52

    No Worsening of NASH is defined as no increase in inflammation, ballooning, or steatosis scores in the NAS score.

  2. Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis

    Time frame: 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.

Secondary outcomes

  1. Compared with placebo, the percentage change in serum alanine aminotransferase (ALT)

    Time frame: At week 24, week 52 and week 82

  2. Compared with placebo, the change in liver fat fraction from baseline and liver fat percentage change from baseline

    Time frame: At week 24 and week 52

    measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)

  3. Compared with placebo, the percentage of participants with a > 30% decrease in liver fat fraction from baseline

    Time frame: At week 24 and week 52

    measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)

  4. Compared with placebo, the change and percentage change in noninvasive markers of fibrosis from baseline: FIB-4, NAFLD fibrosis score, and AST/PLT ratio index (APRI)

    Time frame: At week 24, week 52 and week 82

  5. Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis

    Time frame: At week 52

    NASH resolution was defined as a NAS score of 0-1 for inflammation, 0 for ballooning, and no increase in steatosis score

  6. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their correlation with VSA006

    Time frame: Up to week 82

  7. Maximum observed concentration (Cmax) of VSA006

    Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

  8. Time of maximum concentration of VSA006 (Tmax)

    Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

  9. Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA006

    Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

  10. anti-drug antibodies (ADAs) of VSA006

    Time frame: up to week 82

Sponsors and collaborators

Lead sponsor

Visirna Therapeutics HK Limited

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 21, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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