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

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LIB Therapeutics LLC
• Collaborator: Medpace, Inc.

Criteria

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;