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Trial Overview

Official Title

A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia

Study Purpose

The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will receive 2 subcutaneous injections of ARO-ANG3 or placebo.


Mixed Dyslipidemia


Inclusion Criteria:

  1. Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL on more than one occasion
  2. Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable optimal statin therapy
  3. Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 14 days apart
  4. Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care
  5. Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
  6. Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
  7. Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

  1. Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule
  2. Active pancreatitis within 12 weeks prior to Day 1
  3. Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
  4. Acute coronary syndrome event within 24 weeks of Day 1
  5. Major surgery within 12 weeks of Day 1
  6. Planned coronary intervention (e.g., stent placement or heart bypass) during the study
  7. Uncontrolled hypertension
  8. Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
  9. Uncontrolled hypothyroidism or hyperthyroidism
  10. Hemorrhagic stroke within 24 weeks of Day 1
  11. History of bleeding diathesis or coagulopathy
  12. Current diagnosis of nephrotic syndrome
  13. Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study
  14. Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)

Note: additional inclusion/exclusion criteria may apply per protocol


Drug: ARO-ANG3

Drug: Placebo

Parallel Assignment

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Key Participation Requirements
Trial Location(s)
Male or Female
18 years and older
Enrollment Status
Active, Not Recruiting
Phase II
Methodist Health System Trial Code