For Healthcare Professionals

Study of ARO-ANG3 in Adults With Mixed Dyslipidemia


About the study

The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL
  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 diet and 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 17 days apart
  4. Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care
  5. Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication
  6. Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
  7. Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
  8. Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
  9. Able and 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 or planned surgery during the study
  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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Mixed Dyslipidemia

Age (in years)



Phase 2

Participants needed


Est. Completion Date

Dec 31, 2024

Treatment type



Arrowhead Pharmaceuticals identifier


Study number


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