Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients (LIBerate-H2H)

This is an interventional treatment trial for Hypercholesterolemia focused on measuring lerodalcibep, evolocumab, alirocumab Read More

Inclusion Criteria:

• signed informed consent
• diagnosed with CVD or a high risk of CVD based on 2019 ESC/EAS guidelines
• Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2
• LDL-C ≥90 mg/dL and TG ≤400 mg/dL while on stable diet & lipid-lowering oral drug therapy (ie, high intensity statin with or without ezetimibe) and no PCSK9 mAb for 4 weeks if previously on Q2W dosing or 8 weeks if on Q4W dosing.
• Females of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test at the last Screening Visit

Exclusion Criteria:

• at screening visit: not on high intensity statin; mipomersen or lomitapide within 6 months; gemfibrozil within 6 weeks; bempedoic acid within 4 weeks; inclisiran within 12 months; apheresis within 8 weeks
• HoFH defined clinically and/or genetically
• History of prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator
• estimated glomerular filtration rate <30 mL/min/1.73m2 at screening
• Active liver disease or hepatic dysfunction, history of liver transplant, and/or AST or ALT >2.5 × the ULN
• Uncontrolled Type 1 or Type 2 diabetes mellitus, defined as fasting glucose ≥200 mg/dL or glycated hemoglobin (HbA1c) of ≥9%
• NY Heart Association class III-IV heart failure; or patients with last documented left ventricular ejection fraction <30%; planned PCI, CABG or cardiac surgery
• Uncontrolled hypertension defined as evidenced by a reproducible (repeated 5 minutes apart) sitting blood pressure ≥160 mmHg systolic or ≥100 mmHg diastolic;
• Enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives since ending another investigational device or drug study(ies), or receiving PCSK9 or Lp(a) siRNA or locked nucleic acid-reducing agents within 12 months of the Screening Visit;
• Have any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;