NCT06322628Active, not recruitingPhase 2
A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients
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)
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 22 Dec 2023
- Start date
- 22 Apr 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Visirna Therapeutics HK Limited
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06322628
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 48
- From 22 Apr 2024 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Participants diagnosed with type 1 diabetes, or with unstable type 2 diabetes
Other
- Pregnant or lactating women;
- Participants who cannot receive an MRI examination;
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tsinghua Changgeng Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.