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Monoclonal Antibodies

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

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
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new drug called LIB003, given as an injection under the skin. It aims to see how well it works in people who are either taking statins or not. The drug is expected to lower bad cholesterol levels in the blood.

Eligible Conditions
  • High Cholesterol

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~940

Find a Location

Who is running the clinical trial?

Medpace, Inc.Industry Sponsor
96 Previous Clinical Trials
29,855 Total Patients Enrolled
LIB Therapeutics LLCLead Sponsor
10 Previous Clinical Trials
4,889 Total Patients Enrolled
Traci A Turner, MDPrincipal InvestigatorMetabolic & Atherosclerosis Research Center
1 Previous Clinical Trials
63 Total Patients Enrolled
~6 spots leftby Dec 2025
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