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

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

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

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: lerodalcibep

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Metabolic & Atherosclerosis Research Center (MARC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LIB003 (lerodalcibep) Process 1; 300 mg LIB003 Process 1 drug product administered SC	Drug: lerodalcibep; 300 mg of each drug given SC as single dose; Other Names: LIB003
ACTIVE_COMPARATOR: LIB003 (lerodalcibep) Process 2; 300 mg LIB003 Process 2 drug product administered SC	Drug: lerodalcibep; 300 mg of each drug given SC as single dose; Other Names: LIB003

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of LDL-C	comparison of serum LDL-C reductions from baseline to week 4 between P1 and P2	4 weeks

Collaborators and Investigators

• Sponsor: LIB Therapeutics LLC
• Collaborators: Medpace, Inc.
• Investigators: Principal Investigator: Traci A Turner, MD, Metabolic & Atherosclerosis Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 28, 2022
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): July 11, 2022

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (ACTUAL): February 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: LIB003-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes