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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2024-10-15

Brief Summary

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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

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Detailed Description

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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

Conditions

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Hypercholesterolemia Atherosclerotic Ischemic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, comparative trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

efficacy parameters (lipids) blinded after randomization

Study Groups

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lerodalcibep

300 mg SC dosed monthly

Group Type EXPERIMENTAL

lerodalcibep

Intervention Type BIOLOGICAL

300 mg

inclisiran

284 mg SC dosed Day 1 and Day 90

Group Type ACTIVE_COMPARATOR

Inclisiran

Intervention Type DRUG

284 mg

Interventions

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lerodalcibep

300 mg

Intervention Type BIOLOGICAL

Inclisiran

284 mg

Intervention Type DRUG

Other Intervention Names

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LIB003 Leqvio

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No