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Monoclonal Antibodies
lerodalcibep for Hypercholesterolemia (LIBerate-FH 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
Stable diet and other lipid lowering oral therapies besides statins and ezetimibe including bile-acid sequestrants, OM-3 compounds, fenofibrate, bezafibrate, nicotinic acid and bempedoic acid or combinations thereof for at least 4 weeks
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
LIBerate-FH Trial Summary
This trial is to see if a new drug reduces LDL-C levels in patients with Heterozygous FH.
Eligible Conditions
- Familial Hypercholesterolemia
LIBerate-FH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been taking medications to lower your cholesterol levels, except for statins and ezetimibe, for at least 4 weeks and your diet has been consistent during that time.
LIBerate-FH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline compared to placebo in LDL-C level
Secondary outcome measures
Change in serum free PCSK9 with LIB003 compared to placebo
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities
LIBerate-FH Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LIB003 (lerodalcibep)Experimental Treatment1 Intervention
300 mg (1.2 mL) SC Q4W
Group II: PlaceboPlacebo Group1 Intervention
1.2 mL 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
4,427 Total Patients Enrolled
8 Trials studying Hypercholesterolemia
3,446 Patients Enrolled for Hypercholesterolemia
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
29,137 Total Patients Enrolled
8 Trials studying Hypercholesterolemia
3,770 Patients Enrolled for Hypercholesterolemia
David Kallend, MB BChStudy DirectorLIB Therapeutics
1 Previous Clinical Trials
2,000 Total Patients Enrolled
1 Trials studying Hypercholesterolemia
2,000 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.
Are patients still being enrolled in this trial?
"This specific trial, as listed on clinicaltrials.gov, is not currently looking for new patients to enroll. The study was first posted on 4/22/2021, and the most recent update was 11/3/2022. Although this research is not open to new participants, there are 75 other trials with active recruitment at this time."
Answered by AI
What is the FDA's official stance on lerodalcibep?
"Lerodalcibep is considered safe, with a score of 3 on our team's Power scale. This is because lerodalcibep is in Phase 3 trials, meaning that there is some data supporting its efficacy and multiple rounds of data supporting its safety."
Answered by AI
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