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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 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

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

Do I qualify?Apply below to find out

Find a Location

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

Lerodalcibep (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04798430 — Phase 3

High Cholesterol Research Study Groups: LIB003 (lerodalcibep)

High Cholesterol Clinical Trial 2023: Lerodalcibep Highlights & Side Effects. Trial Name: NCT04798430 — Phase 3

Lerodalcibep (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04798430 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being asked to participate in this research project?

"No, this particular trial is no longer recruiting patients. As stated on clinicaltrials.gov, this study was first posted on December 3rd 2020 and had its last edit on August 6th 2021. There are 514 other trials that are still open to enrollment though."

Answered by AI

Could you please elucidate the risks associated with lerodalcibep?

"There is both efficacy and safety data available for this medication, as it has progressed to Phase 3 clinical trials. Therefore, our team rates the safety of lerodalcibep as a 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction

2020. "Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04798430.