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

Nash Clinical Trial

Official 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06322628
• Other study ID #: VSA006-2001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: Visirna Therapeutics HK Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Nash

Intervention

Drug:
• VSA006
every 12 weeks, subcutaneous injections
• Placebo
every 12 weeks, subcutaneous injections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Visirna Therapeutics HK Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving = 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH	No Worsening of NASH is defined as no increase in inflammation, ballooning, or steatosis scores in the NAS score.	At week 52
Primary	Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis	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.	At week 52
Secondary	Compared with placebo, the percentage change in serum alanine aminotransferase (ALT)		At week 24, week 52 and week 82
Secondary	Compared with placebo, the change in liver fat fraction from baseline and liver fat percentage change from baseline	measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)	At week 24 and week 52
Secondary	Compared with placebo, the percentage of participants with a > 30% decrease in liver fat fraction from baseline	measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)	At week 24 and week 52
Secondary	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)		At week 24, week 52 and week 82
Secondary	Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis	NASH resolution was defined as a NAS score of 0-1 for inflammation, 0 for ballooning, and no increase in steatosis score	At week 52
Secondary	Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their correlation with VSA006		Up to week 82
Secondary	Maximum observed concentration (Cmax) of VSA006		Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Secondary	Time of maximum concentration of VSA006 (Tmax)		Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Secondary	Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA006		Pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Secondary	anti-drug antibodies (ADAs) of VSA006		up to week 82