Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients

Not yet recruiting
Trial end date:
Target enrollment:
Participant gender:
Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy
Phase 3
Accepts Healthy Volunteers?
Lead Sponsor:
LIB Therapeutics LLC
Medpace, Inc.
Inclusion Criteria:

- Provision of signed informed consent prior to any study-specific procedure;

- Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥16 and ≤42 kg/m2;

- Very- high or high risk for CVD as defined in 2019 ESC/EAS Guidelines

- High-intensity statin (daily atorvastatin 40/80 or rosuvastatin 20/40) without other
acceptable oral lipid lowering treatment plus diet; stable >4 weeks with LDL-C ≥85
mg/dL and triglycerides ≤400 mg/dL

- Women of childbearing potential (WOCBP) must continue using a highly effective form of
birth control if sexually active

- Males whose partners are of CBP and not using a highly effective form of birth control
will either be surgically sterile or agree to use the following forms of
contraception, male or female condom with spermicide

Exclusion Criteria:

- Prior or active clinical condition or acute and/or unstable systemic disease,
including cancer, compromising patient inclusion or preclude completion of the study,
at the discretion of the Investigator

- Homozygous FH

- non-high intensity statins, mipomersen, lomitapide, gemfibrozil, and bempedoic acid

- PCSK9 mAb within 4 weeks of screening or siRNA within 1 year

- Severe renal dysfunction, defined eGFR <30 ml/min

- Recent, within 3 months of screening, atherosclerotic event or intervention

- planned cardiac procedure

- NYHA class III or IV heart failure

- active liver disease

- uncontrolled diabetes defined as fasting glucose >200 mg/dL and HbA1c > 9%

- uncontrolled BP ≥180 mmHg systolic or ≥110 mmHg diastolic;