Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product

LIB Therapeutics

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: lerodalcibep

Study type: Interventional

Funder types: Industry

Identifiers

NCT05234775

LIB003-014

Details and patient eligibility

About

To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin therapy

Full description

Comparison of the pharmacokinetics (PK), and pharmacodynamics (free PCSK9 and LDL-C) of single subcutaneous (SC) doses of 300 mg of both LIB003 drug product manufactured by Process 1 (P1) and Process 2 (P2) in subjects with or without statin therapy

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of written and signed informed consent prior to any study-specific procedure
• LDL-C 70 mg/dL or above on stable diet alone or diet plus statin
• Weight of 40 kg (88 lb) and body mass index (BMI) between 17 and 42 kg/m2
• Females of childbearing potential must be using a highly effective form of birth control
• Male subjects will either be surgically sterile or agree, or partner agrees, to use highly effective form of birth control

Exclusion criteria

• Fasting triglyceride >400 mg/dL
• excluded lipid lowering medication
• severe renal impairment (eGFR <30 ml/min)
• fasting glucose >200 mg/dL plus HbA1c >9%
• hepatic transaminases >2.5 x ULN for laboratory
• History of any prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion, at the discretion of the Investigator,
• NYHA class III-IV heart failure or last documented left ventricular EF <30%
• Any severe or clinically significant advert event, laboratory abnormality, intercurrent illness, or other medical condition which indicates to the Investigator that continued participation is not in the best interest of the subject

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

LIB003 (lerodalcibep) Process 1

Experimental group

Description:

300 mg LIB003 Process 1 drug product administered SC

Treatment:

Drug: lerodalcibep

LIB003 (lerodalcibep) Process 2

Active Comparator group

Description:

300 mg LIB003 Process 2 drug product administered SC

Treatment:

Drug: lerodalcibep