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VSA003

Phase 3

Homozygous Familial Hypercholesterolemia (HoFH) | Small molecule | Metabolic |Arrowhead Pharmaceuticals, Inc.|Last Updated: May 5, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

VSA003 · 2 trials · 4 indications

Phase 3 1Phase 1 1
NCT06712771A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of VSA003 in Chinese HoFH PatientsHomozygous Familial Hypercholesterolemia (HoFH)
ACTIVE NOT_RECRUITING46 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of VSA003 in Chinese HoFH Patients
Homozygous Familial Hypercholesterolemia (HoFH)Unlock trial analytics

Study Endpoints

Primary Endpoints

Percent change from baseline in serum LDL-C at month 6
At month 6
Frequency and severity of adverse event (AE) and serious adverse event (SAE)
Up to 85±3 days post-dose

safety and tolerability

Secondary Endpoints

Percent change and absolute change in serum ANGPTL3 levels from baseline at month 6
At month 6
Percent change and absolute change in serum LDL-C, ApoB, non-HDL-C, VLDL-C, TC and TG levels from baseline
Up to month 6, Up to month 18
Percent change and absolute change in serum HDL-C, ApoC-III, ApoC-II, ApoA-I, ApoA-V and Lp[a] levels from baseline
Up to month 6, Up to month 18
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VSA003EXPERIMENTALsubcutaneous injections
PlaceboPLACEBO_COMPARATORsubcutaneous injections

Interventions

NameTypeDescription
VSA003DRUGsubcutaneous injections
PlaceboDRUGsubcutaneous injections
0.9% NaClDRUGplacebo
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:China
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Frequently asked questions about VSA003

What is VSA003 used for?

VSA003 is an investigational small molecule being developed for dyslipidemias and homozygous familial hypercholesterolemia (HoFH). It is being studied in Chinese patients with these conditions, including a Phase 3 trial in HoFH patients aged 12 years and older.

Who is developing VSA003?

VSA003 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARWR. The company is conducting clinical trials of VSA003 in China for dyslipidemias and homozygous familial hypercholesterolemia.

What phase is VSA003 in?

VSA003 is in clinical development. A Phase 1 study in healthy volunteers has been completed, and a Phase 3 trial in patients with homozygous familial hypercholesterolemia is active but not recruiting. It is not yet approved by regulatory authorities.

What clinical trials is VSA003 in?

VSA003 has two clinical trials. NCT05851066 is a completed Phase 1 study in Chinese healthy volunteers with dyslipidemias. NCT06712771 is an active Phase 3 trial in Chinese patients with homozygous familial hypercholesterolemia, with an enrollment of 46 participants.

Is VSA003 the same as any other drug?

No alternative names for VSA003 have been disclosed. The drug is referred to solely as VSA003 in clinical trial records and by its developer, Arrowhead Pharmaceuticals.