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

Hypercholesterolemia Clinical Trial

— LIBerate-VI  

Official title:

Randomized Open Label, Phase 3 Study to Compare the Efficacy and Safety of Lerodalcibep (LIB003) to Inclisiran in Patients at Very High or High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05004675
• Other study ID #: LIB003-012
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 20, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: December 2023
• Source: LIB Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: July 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Atherosclerotic Ischemic Disease
• Hypercholesterolemia

Intervention

Biological:
• lerodalcibep
300 mg

Drug:
• Inclisiran
284 mg

Locations

Country	Name	City	State
France	Hopitaux de Marseille	Marseille	Cedex 05
France	CHU de Nantes - Hôpital Nord Laennec	Nantes	Cedex 01
Germany	Universitätsklinikum Heidelberg - Medizinische Klinik	Heidelberg
Norway	The Lipid Clinic (Oslo University Hospital)	Oslo	Nydalen
Spain	Hospital Universitario Miguel Servet	Zaragoza
United Kingdom	Ashton Medical Group	Ashton-Under-Lyne	Lancashire
United Kingdom	Oak Tree Surgery and Pensilva Health Centre	Liskeard	Cornwall

Sponsors (2)

Lead Sponsor	Collaborator
LIB Therapeutics LLC	Medpace, Inc.

Countries where clinical trial is conducted

France,  Germany,  Norway,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C change	Percent LDL-C change from baseline	Day 270
Secondary	Adverse Events	frequency and severity of injection site reactions (ISRs)	270 days
Secondary	Serum free PCSK9 levels	Percent change in free PCSK9 from baseline	Day 270
Secondary	Apolipoproteins	Percent change in Apo B and Lp(a) from baseline	Day 270
Secondary	Treatment goal achievement	Percent of patients reaching ESC/EAS treatment goals	Day 270