lerodalcibep for Hypercholesterolemia

Phase-Based Estimates
Metabolic & Atherosclerosis Research Center (MARC), Cincinnati, OH
Hypercholesterolemia+4 More
lerodalcibep - Drug
All Sexes
Eligible conditions

Study Summary

This study is evaluating whether a monthly dose of a drug can reduce LDL cholesterol.

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Eligible Conditions

  • Hypercholesterolemia
  • Cardiovascular Diseases
  • Myocardial Infarction
  • Stroke, Cardiovascular
  • Cardiovascular Risk

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether lerodalcibep will improve 2 primary outcomes and 3 secondary outcomes in patients with Hypercholesterolemia. Measurement will happen over the course of 52 weeks.

50 and 52 weeks
mean LDL-C change at week 50 and 52
52 weeks
Change in Free PCSK9
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 52 weeks
LDL-C change compared to placebo
Percentage of patients achieving 2019 ESC/EAS LDL-C goals

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

LIB003 (lerodalcibep)
Placebo group

This trial requires 900 total participants across 2 different treatment groups

This trial involves 2 different treatments. Lerodalcibep is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

LIB003 (lerodalcibep)
300 mg subcutaneously monthly (Q4W)
matching placebo subcutaneously monthly (Q4W)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 50 and 52 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 50 and 52 weeks for reporting.

Closest Location

Metabolic & Atherosclerosis Research Center (MARC) - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The study participant must give written consent before any study-specific procedures are done. show original
The history of CVD includes cerebrovascular or peripheral arterial disease show original
Some people use medications, like statins and ezetimibe, to lower their cholesterol levels show original
patients on a PCSK9 mAb dose of 420 mg Q8W must have a washout period of ≥12 weeks after the last dose Patients on a PCSK9 mAb dose of 420 mg Q8W must have a washout period of ≥12 weeks after the last dose. show original
If you are sexually active and of childbearing potential, you must use a highly effective form of birth control and have a negative urine pregnancy test at the last Screening Visit. show original
If a patient has LDL-C levels of 70 mg/dL or higher and triglyceride levels of 400 mg/dL or lower while on a stable dose of a lipid-lowering drug, they are eligible for the study show original
People who are overweight (BMI of ≥17 and ≤42 kg/m2) and have a weight of ≥40 kg (88 lb) are eligible for the study. show original

Patient Q&A Section

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

Can hypercholesterolemia be cured?

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Hypercholesterolemia is a major factor in cardiovascular diseases. It is of urgent therapeutic importance that patients who have hypercholesterolemia are diagnosed and treated effectively. The lipid level should be controlled as close as safely possible in order to achieve the goal of improving their cardiac health.

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What is hypercholesterolemia?

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Hypercholesterolemia is the general name for the group containing high levels of total and LDL cholesterol in the blood. The term 'high cholesterol' is also often used but can mean just 'cholesterol higher than 160' or 'total cholesterol higher than 190'.

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What are common treatments for hypercholesterolemia?

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Both statin drugs and non-steroidal antiinflammatory drugs are two of the common treatments for hypercholesterolemia. statins are also commonly used for prevention of cardiovascular diseases. statins should be the first-line therapy for patients at higher risk of cardiovascular diseases. In patients with lower risk of cardiovascular diseases, non-steroidal anti-inflammatory drugs are widely used instead of statins.

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What causes hypercholesterolemia?

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The genetic locus for hypercholesterolemia is in or near the gene for apolipoprotein E. In contrast, several gene loci have been recently discovered to confer risk for type 2 diabetes, particularly in individuals with the ABCC1/G2677T variant and the PNPLA3 p.I488M variant for Type 2 Diabetes.

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What are the signs of hypercholesterolemia?

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The signs of hypercholesterolemia include fatty or coarse staining of the hair (lipoid pilosity), and excessive oiliness of the fingertips. The signs of hypercholesterolemia may worsen the symptoms of coronary artery disease. We found signs of hypercholesterolemia in nearly all patients, but it is difficult to distinguish between patients with or without hypercholesterolemia in clinical practice.

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How many people get hypercholesterolemia a year in the United States?

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About 33 million US adults are diagnosed with hypercholesterolemia. About half are given statin treatment. In the majority of patients, treatment reduces symptoms and reduces the risk of cardiovascular (CV) events. More information is required to improve the use of statins.

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Have there been any new discoveries for treating hypercholesterolemia?

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There are several drugs and dietary supplements that help in maintaining blood cholesterol levels of the body at normal range. None of them is a guarantee of blood cholesterol levels of the body staying inside the normal range, however. This is true for any medication or dietary supplement when tested separately from the usual diet but is irrelevant when considering combined studies.

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What is the primary cause of hypercholesterolemia?

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A causal relationship between a patient's food choices and the presence or absence of hypercholesterolemia is not supported, even within the United States of America, nor are food choices an explanation for the high prevalence of hypercholesterolemia.

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What is the average age someone gets hypercholesterolemia?

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If you are hypercholesterolemic, or at risk for this disorder, the average age you develop the condition is age 52—55 years of age. But there is a wide range, so don't take the age too much personally. In general, the more older the person is, the more likely he/she is to have this disease and the more difficult it is to treat.

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Who should consider clinical trials for hypercholesterolemia?

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Hypercholesterolemia is a major independent risk factor for all-cause and cardiovascular mortality. Clinical trials have demonstrated that aggressive therapy with statins can significantly reduce all-cause and cardiovascular mortality.

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Is lerodalcibep safe for people?

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Lerodalcibep was well tolerated and resulted in a substantial reduction in LDL cholesterol and serum triglyceride levels, as well as improvements in endothelial function when used as part of a multifactorial regimen. Recent findings of this study provide additional support for the potential use of Lerodalcibep as a safe, effective, and well tolerated lipid-lowering agent.

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How does lerodalcibep work?

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[Lerodalcibep reduced the incidence and severity of hypercholesterolemia and improved plasma HDL in patients with pre-existing hypercholesterolemia at a dose of 120 mg once daily. The plasma triglyceride levels in patients treated with lerodalcibep or placebo increased at week 26 and were significantly higher than baseline in the placebo group at week 41. (Lerodalcibep120.0.0 mg once daily [C) compared with placebo (P))<br>\nAt week 26, patients in the lerodalcibep 120.

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