Lerodalcibep for High Cholesterol (LIBerate-OLE Trial)

Palo Alto (17 mi)

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.

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.

Exclusion Criteria

I haven't taken specific cholesterol-lowering drugs in the last 6 months.

Treatment Details

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.

1Treatment groups

Experimental Treatment

Group I: LIB003 (lerodalcibep)Experimental Treatment1 Intervention

300 mg monthly (Q4W) by subcutaneous injection