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AROANG3-2001

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.

Diagnosis

Mixed Dyslipidemia

Eligibility

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

Intervention

Drug: ARO-ANG3

Drug: Placebo

Parallel Assignment

For more information, visit ClinicalTrials.gov 

Key Participation Requirements
Trial Location(s)
Gender
Male or Female
Age
18 years and older
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
NCT04832971