Status:
COMPLETED
Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients
Lead Sponsor:
LIB Therapeutics LLC
Conditions:
Hypercholesterolemia
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Comparison of LDL-C reductions at Week 12 of monthly (Q4W\[≤ 31 days\]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) ...
Detailed Description
This is a randomized, open-label Phase 3 study of 12 weeks duration comparing Q4W SC doses of LIB003 300 mg, evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg. Approximately 220 males and f...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04790513
Start Date
April 22 2021
End Date
December 31 2022
Last Update
March 29 2023
Active Locations (3)
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1
Sterling Research Group
Cincinnati, Ohio, United States, 45219
2
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
3
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States, 45227