Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.

You may be able to join if

• 1. Patient has received study drug through the end of study (EOS) with a complete EOS Visit in 1 of the Phase 3 base studies, LIB003-003, -004, - 005, -006, -008, -011 and -012, without SAEs related to LIB003;
• 2. Patient has the provision of written and signed informed consent prior to any study-specific procedure;
• 3. Female patients of childbearing potential must continue using a highly effective form of birth control if sexually active and have a negative urine pregnancy test on Day 1 prior to dosing; o Note: Highly effective methods of birth control include refraining from heterosexual sexual intercourse during the entire period of risk, birth control pills or patches, intrauterine devices (IUDs), sexual activity with a male partner who has had a vasectomy, IUD, oral, implantable, or injectable contraceptives. Menopause is defined as 1 year of spontaneous and continuous amenorrhea in a female ≥55 years old or 1 year of spontaneous and continuous amenorrhea with a folliclestimulating hormone (FSH) level >40 IU/L (or according to the definition of "postmenopausal range" for the laboratory involved) in a female <55 years old unless the patient has undergone bilateral oophorectomy. Birth control should be maintained for 60 days after the last dose of study drug (ie, 30 days after the last study visit). Postmenopausal women and those who are sterilised will be deemed of non-childbearing potential. All other women will be considered of childbearing potential and will be required to follow the contraception requirements as well as the pregnancy testing in the protocol. o Note: WOCBP will also have a pregnancy test prior to randomization, every 4 weeks for the duration of the study and at the final visit. Any participant who considers they or their partner is pregnant should undergo a pregnancy test until 60 days after last dose of study drug and if there is a positive test should follow the standard guidance for pregnancy in the clinical trial.
• 4. Male patients will either be surgically sterile or agree to continue to use the following forms of contraception if their partner is of childbearing potential and not using a highly effective form of birth control as defined in Inclusion Criterion #3: male or female condom with spermicide and a female partner who is sterile or who agrees to use the following contraceptives; diaphragm or cervical cap with spermicide; or intrauterine device, oral, implantable, or injectable contraceptives;
• 5. Male patients must refrain from sperm donation until 90 days following the last dose of study drug;
• 6. Patient is willing to maintain appropriate diet and stable dose of current LLT, including statins, ezetimibe, bile acid sequestrants, niacin, lomitapide, bempedoic acid, bezafibrate or fenofibrate, and/or OM-3 compounds; and o Note: Use of lomitapide will be allowed in patients from LIB003-003. o Note: Use of bempedoic acid will be allowed in patients from LIB003- 004, -005, and -006. o Note: Patients still requiring apheresis may add the procedure after Week 12.