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

Hypercholesterolemia Clinical Trial

Official title:

Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product in Subjects With or Without Statin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234775
• Other study ID #: LIB003-014
• Status: Completed
• Phase: Phase 3
• Start date: January 28, 2022
• Est. completion date: July 11, 2022

Study information

• Verified date: July 2022
• Source: LIB Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 11, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• lerodalcibep
300 mg of each drug given SC as single dose

Locations

Country	Name	City	State
United States	Metabolic & Atherosclerosis Research Center (MARC)	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
LIB Therapeutics LLC	Medpace, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacodynamics	comparison of free PCSK9 reductions from baseline between P1 and P2	4 weeks
Primary	Cmax pharmacokinetics	comparison of serum lerodalcibep Cmax between P1 and P2	4 weeks
Primary	AUC 0-last pharmacokinetics	comparison of serum lerodalcibep AUC 0-last between P1 and P2	4 weeks
Primary	T-Half pharmacokinetics	comparison of serum lerodalcibep T-HALF between P1 and P2	4 weeks
Secondary	comparison of LDL-C	comparison of serum LDL-C reductions from baseline to week 4 between P1 and P2	4 weeks