Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
Condition: Mixed Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: ARO-ANG3; Placebo
Intervention description: ARO-ANG3 Injection; Sterile Normal Saline (0.9% NaCl)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Based on medical history, evidence of 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 during Screening collected at two separate
             and consecutive visits and at least 7 days apart and not more than 17 days apart

          -  Willing to follow diet counseling and maintain a stable diet per Investigator judgment
             based on local standard of care

          -  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

          -  Women of childbearing potential must have a negative pregnancy test and cannot be
             breastfeeding

          -  Women of childbearing potential on hormonal contraceptives must be stable on the
             medication for ≥ 2 menstrual cycles prior to Day 1

          -  Men must not donate sperm during the study and for at least 24 weeks following the
             last dose of study medication

          -  Able and willing to provide written informed consent and to comply with study
             requirements

        Exclusion Criteria:

          -  Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or
             antisense oligonucleotide molecule

          -  Active pancreatitis within 12 weeks prior to Day 1

          -  Any planned bariatric surgery or similar procedures to induce weight loss from consent
             to end of study

          -  Acute coronary syndrome event within 24 weeks of Day 1

          -  Major surgery within 12 weeks of Day 1 or planned surgery during the study

          -  Planned coronary intervention (e.g., stent placement or heart bypass) during the study

          -  Uncontrolled hypertension

          -  Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV),
             seropositive for Hepatitis C (HCV)

          -  Uncontrolled hypothyroidism or hyperthyroidism

          -  Hemorrhagic stroke within 24 weeks of Day 1

          -  History of bleeding diathesis or coagulopathy

          -  Current diagnosis of nephrotic syndrome

          -  Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or
             planned use during the study

          -  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