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

NCT05234775 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: LIB003-014
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• comparison of LDL-C

  4 weeks

Study Arms (2)

LIB003 (lerodalcibep) Process 1

EXPERIMENTAL

300 mg LIB003 Process 1 drug product administered SC

Drug: lerodalcibep

LIB003 (lerodalcibep) Process 2

ACTIVE COMPARATOR

300 mg LIB003 Process 2 drug product administered SC

Drug: lerodalcibep

Interventions

lerodalcibep DRUG

300 mg of each drug given SC as single dose

Also known as: LIB003

LIB003 (lerodalcibep) Process 1; LIB003 (lerodalcibep) Process 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Metabolic & Atherosclerosis Research Center (MARC)

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Traci A Turner, MD

  Metabolic & Atherosclerosis Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: assignment to initial treatment group with cross over to alternate treatment group

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 10, 2022
• Study Start: January 28, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 11, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)