Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arrowhead Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
