Status:
COMPLETED
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Mixed Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pla...
Eligibility Criteria
Inclusion
- 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 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
- 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
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2024
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04832971
Start Date
June 28 2021
End Date
September 25 2024
Last Update
December 3 2025
Active Locations (24)
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1
Research Site 5
Huntington Park, California, United States, 90255
2
Research Site 7
Hialeah, Florida, United States, 33012
3
Research Site 17
Miami, Florida, United States, 33144
4
Research Site 8
Port Orange, Florida, United States, 32127