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

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: lerodalcibep

• Registration Number: NCT05234775
• Lead Sponsor: LIB Therapeutics LLC

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2022-01-17
• Study Start: 2022-01-28
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-10
• Primary Completion: 2022-06-30
• Status Verified: 2022-07
• Study Completion: 2022-07-11
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LIB003 (lerodalcibep) Process 1	lerodalcibep	300 mg LIB003 Process 1 drug product administered SC
LIB003 (lerodalcibep) Process 2	lerodalcibep	300 mg LIB003 Process 2 drug product administered SC

Primary Outcome Measures

Name	Time	Method
pharmacodynamics	4 weeks	comparison of free PCSK9 reductions from baseline between P1 and P2
Cmax pharmacokinetics	4 weeks	comparison of serum lerodalcibep Cmax between P1 and P2
AUC 0-last pharmacokinetics	4 weeks	comparison of serum lerodalcibep AUC 0-last between P1 and P2
T-Half pharmacokinetics	4 weeks	comparison of serum lerodalcibep T-HALF between P1 and P2

Secondary Outcome Measures

Name	Time	Method
comparison of LDL-C	4 weeks	comparison of serum LDL-C reductions from baseline to week 4 between P1 and P2

Trial Locations

Locations (1)

Metabolic & Atherosclerosis Research Center (MARC); 🇺🇸 Cincinnati, Ohio, United States