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

NCT05004675 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: LIB003-012
• Study Type: interventional
• Target: 166
• Locations: 5 countries
• Sites: 7

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

Conditions

Hypercholesterolemia; Atherosclerotic Ischemic Disease

Keywords

lerodalcibep; PCSK9 inhibitor; inclisiran

Outcome Measures

Primary Outcomes (1)

• LDL-C change

  Percent LDL-C change from baseline

  Day 270

Secondary Outcomes (4)

• Adverse Events

  270 days

• Serum free PCSK9 levels

  Day 270

• Apolipoproteins

  Day 270

• Treatment goal achievement

  Day 270

Study Arms (2)

lerodalcibep

EXPERIMENTAL

300 mg SC dosed monthly

Biological: lerodalcibep

inclisiran

ACTIVE COMPARATOR

284 mg SC dosed Day 1 and Day 90

Drug: Inclisiran

Interventions

lerodalcibep BIOLOGICAL

300 mg

Also known as: LIB003

lerodalcibep

Inclisiran DRUG

284 mg

Also known as: Leqvio

inclisiran

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• LIB Therapeutics LLC: lead
• Medpace, Inc.: collaborator

Study Sites (7)

CHU de Nantes - Hôpital Nord Laennec

Nantes, Cedex 01, 44093, France

Location

Hopitaux de Marseille

Marseille, Cedex 05, 13385, France

Location

Universitätsklinikum Heidelberg - Medizinische Klinik

Heidelberg, 69120, Germany

Location

The Lipid Clinic (Oslo University Hospital)

Oslo, Nydalen, 424, Norway

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Oak Tree Surgery and Pensilva Health Centre

Liskeard, Cornwall, PL14 3XA, United Kingdom

Location

Ashton Medical Group

Ashton-under-Lyne, Lancashire, OL6 6EW, United Kingdom

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Evan A Stein, MD PhD

  LIB Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: efficacy parameters (lipids) blinded after randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, comparative trial

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: June 20, 2022
• Primary Completion: May 30, 2024
• Study Completion: October 15, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); FR (2); ES (1); GB (2); DE (1)