Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction

Randomized, Double-Blind, Placebo-Controlled, Phase 2 study to assess the LDL-C lowering
efficacy at Week 12 of various doses of LIB003 administered subcutaneously (SC) every 4 weeks
(Q4W) in patients with hypercholesterolemia on stable diet and oral LDL-C-lowering drug
therapy.

Inclusion Criteria:

1. Male or female, 18 years of age or older

2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic
cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high
risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years and older with
diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or
greater or heterozygous familial hypercholesterolemia (HeFH)

3. Body mass index (BMI) between 18 and 40 kg/m2

Exclusion Criteria:

1. Females of childbearing potential not using or willing to use an effective form of
contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy
test at screening

2. Homozygous familial hypercholesterolemia

3. LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months

4. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or
stroke within 3 months prior to enrollment

5. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or
stroke within 3 months prior to enrollment

6. Newly diagnosed or poorly controlled (HbA1c >9%) type 2 diabetes

7. Uncontrolled hypertension

8. Moderate to severe renal insufficiency

9. Elevated liver function test at screening

10. Uncontrolled cardiac arrhythmia or prolonged QT on EKG

11. A history of prescription drug abuse, illicit drug use, or alcohol abuse