LIBerate-VI: Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: lerodalcibep 300 mg SC dosed monthly |
Biological: lerodalcibep
300 mg
Other Names:
|
| Active Comparator: inclisiran 284 mg SC dosed Day 1 and Day 90 |
Drug: Inclisiran
284 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- LDL-C change [Day 270]
Percent LDL-C change from baseline
Secondary Outcome Measures
- 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
Eligibility Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Heidelberg - Medizinische Klinik | Heidelberg | Germany | 69120 | |
| 2 | Royal Free Hospital, Pond Street | London | United Kingdom | NW3 2QG |
Sponsors and Collaborators
- LIB Therapeutics LLC
- Medpace, Inc.
Investigators
- Study Director: Evan A Stein, MD PhD, LIB Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LIB003-012