Atherosclerotic Ischemic Disease, Hypercholesterolemia
Conditions
Keywords
lerodalcibep, PCSK9 inhibitor, inclisiran
Brief 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
Detailed description
Randomized, Open Label (lipids blinded), Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) at Day 270 of subcutaneous (SC) monthly (QM \[≤31 days\]) lerodalcibep (LIB003) 300 mg administered to SC inclisiran (Leqvio®) 284 mg at Days 1 and 90 in patients with very-high risk or high-risk CVD or at high risk for CVD with LDL-C ≥85 mg/dL on a stable diet and oral LDL-C-lowering drug therapy
Interventions
BIOLOGICALlerodalcibep
300 mg
DRUGInclisiran
284 mg
Sponsors
Medpace, Inc.
LIB Therapeutics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
efficacy parameters (lipids) blinded after randomization
Intervention model description
randomized, comparative trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C change | Day 270 | Percent LDL-C change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 270 days | frequency and severity of injection site reactions (ISRs) |
| Serum free PCSK9 levels | Day 270 | Percent change in free PCSK9 from baseline |
| Apolipoproteins | Day 270 | Percent change in Apo B and Lp(a) from baseline |
| Treatment goal achievement | Day 270 | Percent of patients reaching ESC/EAS treatment goals |
Countries
France, Germany, Norway, Spain, United Kingdom
Outcome results
None listed