Clinical trial
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)
Name
VSA006-2001
Description
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.
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-12-01
Trial end
2026-07-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
VSA006
every 12 weeks, subcutaneous injections
Arms:
VSA006 high dose, VSA006 low dose
Placebo
every 12 weeks, subcutaneous injections
Arms:
VSA006 high dose comparator, VSA006 low dose comparator
Size
45
Primary endpoint
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH
At week 52
Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis
At week 52
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2024-03-21
1 organization
2 products
1 indication
Product
VSA006Indication
Nonalcoholic steatohepatitis (NASH)Organization
Visirna TherapeuticsProduct
Placebo