🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06712771
Active, not recruiting Phase 3

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of VSA003 in Chinese HoFH Patients

NCT06712771 · tracked via the Priya Life Science China tracker
Sponsor
Visirna Therapeutics HK Limited
Phase
Phase 3
Started
2024-11-27
Last updated
2026-05-05

Condition(s) studied

Homozygous Familial Hypercholesterolemia (HoFH)

Investigational drug(s) / intervention(s)

VSA003Placebo

VSA003: subcutaneous injections

Placebo: subcutaneous injections

Study summary

Significant reduction in ANGPLT3 levels is expected to reduce plasma LDL-C and TG levels and may lead to the reduction of risk of coronary heart disease and cardiovascular events associated with hypertriglyceridemia and LDL-C in subjects with persistent dyslipidemia. In this clinical study, the efficacy and safety of VSA003, an RNAi-based therapeutic targeting ANGPTL3, will be evaluated in subjects with HoFH.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Male or female aged ≥ 12 years and weighing ≥ 40 kg at the time of ICF signature; * Patients with HoFH who meet genetic or clinical diagnosis; * Willing to follow a daily low-fat diet for the duration of the study; * Receiving stable and tolerable lipid-lowering therapy prior to LDL-C testing during the screening period; * Fasting LDL-C ≥ 2.6 mmol/L. Exclusion Criteria: * Have received or are receiving targeted ANGPTL3 treatment within 5 months or 5 half-lives, whichever is longer, prior to screening; * Fasting TG ≥ 4.5 mmol/L at screening; * Presence of uncontrolled endocrine disease affecting lipids or lipoproteins; * Weight change of more than 10% in the 4 weeks prior to randomisation; * Initiation of a new dietary plan or significant differences from previous dietary structure and habits within 4 weeks prior to screening; * Women who are pregnant (including planned pregnancies) or breastfeeding; * Refusal to limit alcohol consumption to moderate limits and below during the study period, specifically no more than 14 units per week; * Uncontrolled hypertension (blood pressure \> 160/100 mmHg at screening); * New York Heart Association (NYHA) class IV heart failure or left ventricular ejection fraction \<30% within 12 months prior to screening; * History of major surgery within 12 weeks prior to baseline, or planning to undergo major surgery during the study; * Known allergy to any component of the study drug.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing China

More Visirna Therapeutics HK Limited trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06712771 on ClinicalTrials.gov ↗ ← All trials in China