Lerodalcibep for High Cholesterol

(LIBerate-OLE Trial)

Recruiting at 11 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: LIB Therapeutics LLC

Must be taking: Lipid-lowering therapy

Must not be taking: PCSK9 mAbs, mipomersen

Disqualifiers: Unstable disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

2000 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires you to stay on your current lipid-lowering medications, like statins or ezetimibe, as long as they are not on the prohibited list. You should not be using certain other medications like PCSK9 mAbs or mipomersen.

What data supports the effectiveness of the drug Lerodalcibep for high cholesterol?

While there is no direct data on Lerodalcibep, similar treatments like statins (e.g., lovastatin) have been shown to significantly lower LDL cholesterol levels, which is a key factor in managing high cholesterol. Additionally, other cholesterol-lowering drugs like ezetimibe and colesevelam have been effective in reducing LDL cholesterol, suggesting that Lerodalcibep may also be effective. ^{1 2 3 4 5}

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive monthly subcutaneous injections of LIB003 300 mg for long-term efficacy and safety assessment

72 weeks

Clinic visits every 4 weeks for the first 12 weeks, then every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lerodalcibep

Trial Overview 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.

Participant Groups

Group I: LIB003 (lerodalcibep) Experimental Treatment 1 Intervention

300 mg monthly (Q4W) by subcutaneous injection

Who Is Running the Clinical Trial?

LIB Therapeutics LLC

Lead Sponsor

Trials

11

Recruited

4,900+

Medpace, Inc.

Industry Sponsor

Trials

98

Recruited

30,400+

Dr. August J. Troendle

Medpace, Inc.

Chief Executive Officer since 1992

MD from the University of Maryland, School of Medicine; MBA from Boston University

Dr. Reinilde Heyrman

Medpace, Inc.

Chief Medical Officer since 2017

MD

Findings from Research

In a study of high-risk patients switched from simvastatin therapy, the combination of ezetimibe/simvastatin led to significantly greater reductions in LDL cholesterol (37 mg/dL) compared to rosuvastatin (25 mg/dL) and atorvastatin (26 mg/dL).

All treatment regimens improved other lipid parameters, such as total cholesterol and triglycerides, with no significant differences in adverse events among the different therapies, indicating a similar safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of ezetimibe/simvastatin, rosuvastatin, and atorvastatin in uncontrolled hyperlipidemia patients. Furman, A., Meier, JL., Malmstrom, RA., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of ezetimibe/simvastatin, rosuvastatin, and atorvastatin in uncontrolled hyperlipidemia patients. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Expanded clinical evaluation of lovastatin (EXCEL) study results: III. Efficacy in modifying lipoproteins and implications for managing patients with moderate hypercholesterolemia. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Cholesterol treatment patterns and cardiovascular clinical outcomes associated with colesevelam HCl and ezetimibe. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

[The pharmacological treatment of hypercholesterolemia]. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of combined probucol-colestipol treatment for familial hypercholesterolemia and coronary artery disease. [2019]