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ARO-ANG3

Phase 2

Mixed Dyslipidemia | Small molecule | Cardiovascular |Arrowhead Pharmaceuticals, Inc.|Last Updated: Dec 24, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment204

FDA Designations

No designations recorded

Clinical trial landscape

ARO-ANG3 · 2 trials · 4 indications

Phase 2 1Phase 1 1
NCT04832971Study of ARO-ANG3 in Adults With Mixed DyslipidemiaMixed Dyslipidemia
COMPLETED204 Analytics
PHASE2COMPLETED
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
Mixed DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Fasting TG at Week 24
Baseline, Week 24
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Up to 113 (+/- 3 days) post-dose

Secondary Endpoints

Percent Change From Baseline in Fasting TG Over Time
Baseline, up to Week 36 (double-blind treatment period)
Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
Baseline, Week 24
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Baseline, up to Week 36 (double-blind treatment period)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARO-ANG3 50 mgEXPERIMENTALTwo doses of ARO-ANG3 by subcutaneous (sc) injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
ARO-ANG3 100 mgEXPERIMENTALTwo doses of ARO-ANG3 bysc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
ARO-ANG3 200 mgEXPERIMENTALTwo doses of ARO-ANG3 by sc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
PlaceboPLACEBO_COMPARATORCalculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
ARO-ANG3EXPERIMENTAL -

Interventions

NameTypeDescription
ARO-ANG3DRUGARO-ANG3 Injection
PlaceboDRUGSterile Normal Saline (0.9% NaCl)
sterile normal saline (0.9% NaCl)DRUGcalculated volume to match active treatment
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Based on medical history, evidence of triglycerides (TG) ≥ 150 mg/dL but ≤ 499 mg/dL * Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy * Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL...

Countries:United StatesAustraliaCanadaNew Zealand
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Frequently asked questions about ARO-ANG3

What is ARO-ANG3 used for?

ARO-ANG3 is an investigational drug being studied for the treatment of dyslipidemias, including mixed dyslipidemia, familial hypercholesterolemia, and hypertriglyceridemia. It is being developed by Arrowhead Pharmaceuticals, Inc. (ARWR) and is currently in clinical development, with studies conducted in healthy volunteers and in patients with dyslipidemia.

What does ARO-ANG3 target?

ARO-ANG3 is a small molecule that targets angiopoietin-like 3 (ANGPTL3), a protein involved in lipid metabolism. By inhibiting ANGPTL3, ARO-ANG3 aims to reduce lipid levels in the blood, which may help treat dyslipidemias. This mechanism is being evaluated in clinical trials for conditions such as mixed dyslipidemia and familial hypercholesterolemia.

Who makes ARO-ANG3?

ARO-ANG3 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARWR. The company is conducting clinical trials to evaluate the safety and efficacy of ARO-ANG3 in patients with dyslipidemias.

What phase is ARO-ANG3 in?

ARO-ANG3 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by the FDA. The development program includes studies in healthy volunteers and in patients with dyslipidemias, with the most advanced trial being a Phase 2 study in adults with mixed dyslipidemia.

What clinical trials is ARO-ANG3 in?

ARO-ANG3 has been studied in two completed clinical trials. NCT03747224 was a Phase 1 study in healthy volunteers and dyslipidemic patients with conditions such as familial hypercholesterolemia and hypertriglyceridemia. NCT04832971 was a Phase 2 study in adults with mixed dyslipidemia, enrolling 204 participants across the United States, Australia, Canada, and New Zealand.

Is ARO-ANG3 the same as any other drug?

ARO-ANG3 is also known by its chemical name, and it is a distinct investigational agent developed by Arrowhead Pharmaceuticals. It is not the same as other approved lipid-lowering drugs, as it specifically targets angiopoietin-like 3 (ANGPTL3) through a small molecule approach, which is different from statins or PCSK9 inhibitors.