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Monoclonal Antibodies
LIB003 for High LDL Cholesterol (LIBerate-CVD 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
Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥4 weeks after the last dose; for those on 300 mg or 420 mg Q4W (≤31 days) the washout period is ≥8 weeks following last dose
Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
LIBerate-CVD Trial Summary
This trial is to see if a drug called LIB003 can reduce LDL-C levels over 52 weeks in patients who are at very high risk for cardiovascular disease and who are already taking other oral LDL-C lowering drugs.
Who is the study for?
This trial is for adults over 18 with cardiovascular disease at very high risk, who need extra help lowering their LDL cholesterol despite being on a stable diet and oral drugs like statins. They must have been on consistent medication doses for at least 4 weeks and not have severe liver issues, recent heart problems or surgeries, uncontrolled diabetes, or serious kidney dysfunction.Check my eligibility
What is being tested?
The study tests the effectiveness of lerodalcibep (LIB003), given as a monthly shot under the skin, in reducing bad cholesterol levels compared to a placebo in patients already taking cholesterol-lowering medications but needing further reduction after one year.See study design
What are the potential side effects?
While specific side effects are not listed here, typical reactions to subcutaneous injections may include pain at the injection site, swelling, redness, bruising or itching. Other side effects could be related to immune response or changes in blood lipid levels.
LIBerate-CVD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stopped my PCSK9 inhibitor medication for at least 4 or 8 weeks, depending on the dose.
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I weigh at least 88 pounds and my BMI is between 17 and 42.
Select...
I am 18 years old or older.
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I am using effective birth control and my pregnancy test was negative.
LIBerate-CVD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
LDL-C change compared to placebo
mean LDL-C change at week 50 and 52
Secondary outcome measures
Free PCSK9 change
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 52 weeks
Percentage of patients achieving 2019 ESC/EAS LDL-C goals
LIBerate-CVD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LIB003 (lerodalcibep)Experimental Treatment1 Intervention
300 mg subcutaneously monthly (Q4W)
Group II: PlaceboPlacebo Group1 Intervention
matching placebo subcutaneously monthly (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?
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
28,745 Total Patients Enrolled
LIB Therapeutics LLCLead Sponsor
10 Previous Clinical Trials
4,005 Total Patients Enrolled
Evan A Stein, MD PhDStudy DirectorLIB Therapeutics
5 Previous Clinical Trials
1,361 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HoFH either through genetic tests or based on my symptoms.I weigh at least 88 pounds and my BMI is between 17 and 42.I have stopped my PCSK9 inhibitor medication for at least 4 or 8 weeks, depending on the dose.I am scheduled for heart surgery or a procedure to improve blood flow.I have severe heart failure.My kidney function is low, with an eGFR under 30.I am not pregnant, breastfeeding, and I use effective birth control.I haven't had major heart issues or strokes in the last 3 months.I haven't taken certain cholesterol medications or undergone specific cholesterol treatments recently.My LDL is 70 or higher, and my triglycerides are 400 or less on my current cholesterol medication.My diabetes is not under control, with high blood sugar or HbA1C levels.I am 18 years old or older.I am using effective birth control and my pregnancy test was negative.I do not have active liver disease, a liver transplant history, or high liver enzyme levels.My thyroid condition is not under control.I have been on a consistent diet and cholesterol medication for at least 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: LIB003 (lerodalcibep)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this program for new participants?
"The clinical trial in question is not presently looking for new recruits. However, this should not discourage patients from seeking out other medical trials, of which there are 430 actively recruiting right now."
Answered by AI
Has the FDA greenlit lerodalcibep for public use?
"There is some evidence of lerodalcibep's efficacy and it has been thoroughly tested for safety, so it received a score of 3."
Answered by AI
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