What side effects are associated with this type of intervention?

Common treatments for high cholesterol include statins and PCSK9 inhibitors. Statins, such as atorvastatin and rosuvastatin, can cause side effects like muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. PCSK9 inhibitors, such as alirocumab and evolocumab, are generally well-tolerated but can cause injection site reactions, nasopharyngitis, and flu-like symptoms. In clinical trials, serious adverse events were similar between PCSK9 inhibitors and placebo groups, with mild injection-site reactions being the most common side effect.

What prior FDA approvals exist?

The FDA has approved several PCSK9 inhibitors for the treatment of high cholesterol, including alirocumab and inclisiran. Alirocumab, evaluated in the ODYSSEY HoFH trial, showed a significant reduction in LDL-C levels. Inclisiran, studied in the ORION-9, -10, and -11 trials, also demonstrated substantial LDL-C lowering effects with a favorable safety profile. These treatments, similar to the PCSK9 inhibitor LIB003 currently under study, offer promising options for patients requiring further LDL-C reduction.

What other types of research exist?

Promising alternatives to LIB003 for high cholesterol patients include evolocumab and alirocumab, both of which are PCSK9 inhibitors with strong efficacy and safety profiles. Additionally, inclisiran, another PCSK9 inhibitor, has shown significant LDL-C reduction in clinical trials (ORION-9, -10, and -11). These treatments are noteworthy for their ability to lower LDL-C levels effectively and are supported by substantial clinical evidence.

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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

Must not have

Use of prohibited oral lipid-lowering agents PCSK9 mAbs, mipomersen, lomitapide gemfibrozil (or bempedoic acid for LIB003, -011) following the base study or the use of PCSK9 short interfering ribonucleic acid (siRNA), or locked nucleic acid-reducing agents (LNA) within the last 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Immunogenicity

LDL Cholesterol reduction

Awards & Highlights

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.

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

~940

0 / 1Eligibility criteria met

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.