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ARO-ANG3

Phase 2

Mixed Dyslipidemia | Small molecule | Metabolic |Arrowhead Pharmaceuticals, Inc.|Last Updated: Dec 3, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment204
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04832971Study of ARO-ANG3 in Adults With Mixed DyslipidemiaPHASE2 COMPLETED 204Jun 28, 2021Sep 25, 2024Dec 3, 202524 United States, Australia +2
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Study Endpoints
Primary Endpoints
Percent Change From Baseline in Fasting TG at Week 24
Baseline, Week 24
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.
Interventions
NameTypeDescription
ARO-ANG3DRUGARO-ANG3 Injection
PlaceboDRUGSterile Normal Saline (0.9% NaCl)
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Eligibility Criteria
Age Range18 Years — 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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