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Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients (LIBerate-VI)

L

LIB Therapeutics

Status and phase

Completed
Phase 3

Conditions

Atherosclerotic Ischemic Disease
Hypercholesterolemia

Treatments

Drug: Inclisiran
Biological: lerodalcibep

Study type

Interventional

Funder types

Industry

Identifiers

NCT05004675
LIB003-012

Details and patient eligibility

About

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

Full 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

Enrollment

166 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

166 participants in 2 patient groups

lerodalcibep
Experimental group
Description:
300 mg SC dosed monthly
Treatment:
Biological: lerodalcibep
inclisiran
Active Comparator group
Description:
284 mg SC dosed Day 1 and Day 90
Treatment:
Drug: Inclisiran

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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