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Monoclonal Antibodies

lerodalcibep for Hypercholesterolemia

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights

Study Summary

This trial is testing if a new medication is as effective and safe as a current medication for people with a specific cholesterol disorder.

Eligible Conditions
  • Hypercholesterolemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 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
Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 24
Secondary outcome measures
The incidence and severity of treatment emergent adverse events (TEAEs)
Other outcome measures
Apoferritins
Lipopolysaccharides
Presence of anti LIB003 antibodies (ADAs)

Side effects data

From 2020 Phase 4 trial • 259 Patients • NCT03096288
5%
chest pain
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
HPR - Evolocumab
HPR - Placebo
NPR - Evolocumab
NPR - Placebo

Trial Design

2Treatment 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
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?

LIB Therapeutics LLCLead Sponsor
10 Previous Clinical Trials
4,840 Total Patients Enrolled
8 Trials studying Hypercholesterolemia
3,859 Patients Enrolled for Hypercholesterolemia
Evan A Stein, MD PhDStudy DirectorLIB Therapeutics
5 Previous Clinical Trials
2,196 Total Patients Enrolled
4 Trials studying Hypercholesterolemia
1,296 Patients Enrolled for Hypercholesterolemia

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
Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH
2019. "Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04034485.
~12 spots leftby Apr 2025
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