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Monoclonal Antibodies

LIB003 (lerodalcibep) Process 1 for High Cholesterol

Phase 3
Waitlist Available
Led By Traci A Turner, MD
Research Sponsored by LIB Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study 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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC 0-last pharmacokinetics
Cmax pharmacokinetics
T-Half pharmacokinetics
+1 more
Secondary outcome measures
comparison of LDL-C

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LIB003 (lerodalcibep) Process 1Experimental Treatment1 Intervention
300 mg LIB003 Process 1 drug product administered SC
Group II: LIB003 (lerodalcibep) Process 2Active Control1 Intervention
300 mg LIB003 Process 2 drug product administered SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lerodalcibep
2022
Completed Phase 3
~770

Find a Location

Who is running the clinical trial?

Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,593 Total Patients Enrolled
LIB Therapeutics LLCLead Sponsor
10 Previous Clinical Trials
4,883 Total Patients Enrolled
Traci A Turner, MDPrincipal InvestigatorMetabolic & Atherosclerosis Research Center
1 Previous Clinical Trials
63 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product
2022. "Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05234775.
~7 spots leftby Apr 2025
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