Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-OLE)

This study is open to adults aged 18 and over. It's specifically for people who have already participated in other Lerodalcibep studies (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011, or LIB003-012).

You would be eligible if you have very high cholesterol, either due to a family history (familial hypercholesterolemia), or if you already have heart and blood vessel disease. You might also be considered if you are at a high risk of developing heart disease.

Crucially, you must already be on a stable dose of other cholesterol-lowering medicines, meaning your current treatment isn’t bringing your cholesterol down enough on its own.

If you take part in this study, you would continue to receive the study drug, Lerodalcibep. The study will involve regular visits to the clinic over a period of up to 72 weeks (about 1.5 years). During these visits, doctors will take blood samples to measure your cholesterol levels and other blood fats, and they will also check for any antibodies against the drug.

You will have physical examinations, electrocardiograms (ECGs) to check your heart, and your vital signs (like blood pressure and pulse) will be monitored. Researchers will also ask about any changes in your health or any side effects you might experience. The aim is to carefully track how the drug affects your body over time.