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Monoclonal Antibodies

Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients (LIBerate-H2H Trial)

Phase 3
Waitlist Available
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 12 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing three injectable medications to lower bad cholesterol in patients with heart disease or at high risk for it. These patients are already on strong cholesterol-lowering treatments. The medications help the body remove more bad cholesterol from the blood.

Eligible Conditions
  • Cardiovascular Disease
  • High Cholesterol

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
LDL-C reduction from baseline at 12 weeks
Secondary study objectives
Achieved ESC/EAS LDL-C goals
tolerability and safety of each treatment: injection site reactions

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

3Treatment groups
Experimental Treatment
Active Control
Group I: LIB003 (lerodalcibep)Experimental Treatment1 Intervention
300 mg SC Q4W
Group II: evolocumabActive Control1 Intervention
420 mg SC Q4W
Group III: alirocumabActive Control1 Intervention
300 mg SC Q4W
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?

LIB Therapeutics LLCLead Sponsor
10 Previous Clinical Trials
4,707 Total Patients Enrolled
Evan A Stein, MD PhDStudy DirectorLIB Therapeutics
5 Previous Clinical Trials
2,063 Total Patients Enrolled
~44 spots leftby Dec 2025
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