Lerodalcibep for High Cholesterol
(LIBerate-OLE Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: LIB Therapeutics LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial involves regular injections of LIB003 for patients with cardiovascular disease or at high risk, including those with certain genetic conditions. The goal is to lower their bad cholesterol levels to help prevent heart disease.

Research Team

David Kallend, MB BCh

Principal Investigator

LIB Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

Provision of written and signed informed consent prior to any study-specific procedure

Successful completion of one of the Phase 3 base studies LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012 without SAEs related to LIB003

Patient is considered by the Investigator to be otherwise healthy

See 2 more

Exclusion Criteria

Not available for protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge

Failure to complete a base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012) study and/or had an SAE that was related to study drug during the base Phase 3 study

Development since the final visit in the base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 or LIB003-012) study of any concomitant clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator

See 2 more

Treatment Details

Interventions

Lerodalcibep (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: LIB003 (lerodalcibep)Experimental Treatment1 Intervention

300 mg monthly (Q4W) by subcutaneous injection