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Monoclonal Antibodies
Lerodalcibep for High Cholesterol (LIBerate-OLE 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights
LIBerate-OLE Trial Summary
This trial is to study the long-term safety, tolerability, and efficacy of a monthly 300 mg dose of LIB003 given to patients with cardiovascular disease or at high risk for cardiovascular disease, who completed one of the LIB003 Phase 3 base studies.
Who is the study for?
This trial is for patients with cardiovascular disease or at high risk, including those with genetic cholesterol disorders (HoFH and HeFH), who've completed a prior Phase 3 study without serious issues from the drug. They must be on stable cholesterol-lowering meds and diet, use effective birth control if applicable, and commit to all study visits.Check my eligibility
What is being tested?
The trial tests long-term safety and effectiveness of lerodalcibep injections every month for up to 72 weeks in lowering 'bad' cholesterol levels. Participants have already finished earlier phases of the study and are continuing their regular cholesterol treatments alongside this new therapy.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to lerodalcibep. These could include typical injection-related responses like pain or swelling at the site, as well as any unexpected health changes.
LIBerate-OLE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks
Secondary outcome measures
Immunogenicity
LDL Cholesterol reduction
LIBerate-OLE Trial Design
1Treatment groups
Experimental Treatment
Group I: LIB003 (lerodalcibep)Experimental Treatment1 Intervention
300 mg monthly (Q4W) by subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lerodalcibep
2022
Completed Phase 3
~770
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for high cholesterol include statins, ezetimibe, and PCSK9 inhibitors. Statins work by inhibiting HMG-CoA reductase, an enzyme involved in cholesterol synthesis in the liver, leading to reduced LDL-C levels.
Ezetimibe reduces cholesterol absorption in the intestines, further lowering LDL-C. PCSK9 inhibitors, such as those studied in the LIB003 trial, work by inhibiting the PCSK9 protein, which normally degrades LDL receptors on liver cells.
By blocking PCSK9, more LDL receptors are available to clear LDL-C from the blood. These treatments are crucial for high cholesterol patients as they significantly lower LDL-C levels, reducing the risk of atherosclerotic cardiovascular disease.
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Who is running the clinical trial?
LIB Therapeutics LLCLead Sponsor
10 Previous Clinical Trials
2,905 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
27,615 Total Patients Enrolled
David Kallend, MB BChStudy DirectorLIB Therapeutics
1 Previous Clinical Trials
478 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using effective birth control and my pregnancy test was negative.I am willing to follow a specific diet and keep my cholesterol medication doses stable.I haven't taken specific cholesterol-lowering drugs in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: LIB003 (lerodalcibep)
Awards:
This trial has 2 awards, including:- 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.
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.
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