Clinical trial NCT05004675: Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Atherosclerotic Ischemic Disease
Keywords: lerodalcibep
PCSK9 inhibitor
inclisiran
Lead sponsor: LIB Therapeutics LLC
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2021-08-13
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, comparative trial
Primary purpose: TREATMENT

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

Eligibility 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;

Primary outcomes:
measure: LDL-C change
timeFrame: Day 270
Secondary outcomes:
measure: Adverse Events
timeFrame: 270 days
measure: Serum free PCSK9 levels
timeFrame: Day 270
measure: Apolipoproteins
timeFrame: Day 270
measure: Treatment goal achievement
timeFrame: Day 270
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes - Hôpital Nord Laennec
state: Cedex 01
city: Marseille
country: France
facility: Hopitaux de Marseille
state: Cedex 05
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg - Medizinische Klinik
city: Oslo
country: Norway
facility: The Lipid Clinic (Oslo University Hospital)
state: Nydalen
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Liskeard
country: United Kingdom
facility: Oak Tree Surgery and Pensilva Health Centre
state: Cornwall
city: Ashton-Under-Lyne
country: United Kingdom
facility: Ashton Medical Group
state: Lancashire
Study officials:
affiliation: LIB Therapeutics
name: Evan A Stein, MD PhD
role: STUDY_DIRECTOR
References: