Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arrowhead Pharmaceuticals
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Fasting LDL-C \>100 mg/dL at Screening
Weight of ≥ 40 kg and body mass index ≥ 18.5 and ≤ 40 kg/m2
Diagnosis of HoFH based on a supportive genetic test or clinical diagnosis
On stable maximally tolerated lipid lowering therapy
Willing to abide by stable low-fat, low-cholesterol, heart-healthy diet for at least 4 weeks prior to Day 1
Participants of childbearing potential (males \& females) must agree to use highly-effective contraception during the study and for at least 24 weeks from the 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 medications for \> 2 menstrual cycles prior to Day 1
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 small interfering RNA oligonucleotides (siRNA) or antisense oligonucleoside molecule
Use of evinacumab (some exceptions apply)
Fasting TG \> 300 mg/dL at Screening
Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
Newly diagnosed (within 3 months prior to informed consent) or poorly controlled diabetes (Hemoglobin A1c \> 9%)
Use of systemic corticosteroids (some exceptions apply)
Symptoms of myocardial ischemia or severe left ventricular dysfunction
History of metastatic malignancy within 3 years of Day 1 (some exceptions apply)
Planned cardiac procedure/surgery such as coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), carotid surgery or stenting, or carotid revascularization
Clareo Health | Study of ARO-ANG3 in Participants With Homozygous Familial Hypercholesterolemia (HOFH)
