lerodalcibep for Hypercholesterolemia

Phase-Based Estimates
2
Effectiveness
3
Safety
Metabolic & Atherosclerosis Research Center (MARC), Cincinnati, OH
Hypercholesterolemia+1 More
lerodalcibep - Biological
Eligibility
18+
All Sexes
Eligible conditions
Hypercholesterolemia

Study Summary

This study is evaluating whether a monthly dose of a drug called evolocumab (Repatha) is as effective as a monthly dose of a drug called alirocumab (Praluent) in lowering LDL cholesterol.

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Eligible Conditions

  • Hypercholesterolemia
  • Cardiovascular Diseases

Treatment Effectiveness

Study Objectives

This trial is evaluating whether lerodalcibep will improve 1 primary outcome and 2 secondary outcomes in patients with Hypercholesterolemia. Measurement will happen over the course of 12 weeks.

12 weeks
Achieved ESC/EAS LDL-C goals
LDL-C reduction from baseline at 12 weeks
tolerability and safety of each treatment: injection site reactions

Trial Safety

Trial Design

3 Treatment Groups

alirocumab
LIB003 (lerodalcibep)

This trial requires 220 total participants across 3 different treatment groups

This trial involves 3 different treatments. Lerodalcibep is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

LIB003 (lerodalcibep)
Biological
300 mg SC Q4W
alirocumab
Biological
300 mg SC Q4W
evolocumab
Biological
420 mg SC Q4W

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 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 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
signed informed consent
diagnosed with CVD or a high risk of CVD based on 2019 ESC/EAS guidelines
Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2
LDL-C ≥90 mg/dL and TG ≤400 mg/dL while on stable diet & lipid-lowering oral drug therapy (ie, high intensity statin with or without ezetimibe) and no PCSK9 mAb for 4 weeks if previously on Q2W dosing or 8 weeks if on Q4W dosing.
Females of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test at the last Screening Visit

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 cardiovascular risk factor. It is highly prevalent in developed nations and is strongly associated with atherosclerosis and coronary heart disease. Statin therapy is the preferred drug for achieving cholesterol goals. Statins reduce cardiovascular events and mortality in men but may be associated with an adverse effect of increasing cancer risk, particularly in women (postmenopausal) who frequently utilize them for high cholesterol management. A possible causal relationship has also been reported between high cholesterol levels and ovarian cancer. The link between statin use and breast cancer risk in a meta-analysis of the randomized controlled trials is still unclear.

Unverified Answer

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

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About 47 million people are diagnosed with hypercholesterolemia in the United States. Hypercholesterolemia is a leading cause of death in the United States. This article reports on key recent findings.

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What are common treatments for hypercholesterolemia?

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Treatment of severe hypercholesterolemia is largely dictated by the magnitude of elevated LDL-C levels and the rate at which LDL-C levels decrease in response to a lipid-lowering regimen. In the pre-statin era, LDL-C was typically treated by reducing total and LDL-C levels with statins, while higher LDL-C levels were treated with dietary modifications. In recent years, statin therapy has typically replaced dietary interventions or lifestyle changes in the treatment of hypercholesterolemia. Newer lipid-lowering agents may provide similar clinical gains at lower lipid concentrations when compared to statins alone.

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What causes hypercholesterolemia?

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Variations in lifestyle and diet are the major factors in the development of hypercholesterolemia because they are related to the enzyme levels involved in cholesterol biosynthesis, metabolism and excretion.

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What is hypercholesterolemia?

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Hypercholesterolemia is a risk factor for cardiovascular disease (CVD). As a consequence, screening for and treatment of hypercholesterolemia might have preventive advantages. In a recent study, findings support current recommendations to take a careful personal medical history of symptoms, as well as to perform a complete cardiovascular risk factor prevention.

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What are the signs of hypercholesterolemia?

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The early signs of hypercholesterolemia include unexplained excessive weight loss. Early signs of hyperhomocapnogeism are abdominal pain, excessive gas filled in the abdomen, abdominal swelling and loss of appetite. People should be checked for early signs of hypercholesterolemia during the early years of life.

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What are the common side effects of lerodalcibep?

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The most commonly reported side effects were headache, nausea and diarrhoea, but they were generally mild and only temporary. In summary, the data suggest that lerodalcibep can be safely administered at its therapeutic dose.

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How does lerodalcibep work?

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Lerodalcibep is an oral steroidal medication aimed to treat hypercholesterolemia which enhances lipid-lowering and anti-inflammatory effects in patients with severe hyperlipidemia, mainly in hypercholesterolemic patients with autoimmune dyslipidemia. This drug is administrated once a day for 8 weeks. The therapeutic efficacy of lerodalcibep seems to be greater than lovastatin.

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How serious can hypercholesterolemia be?

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Hypercholesterolemia can be an urgent problem for patients in their 30s and 40s, especially for those who do not have family members with premature coronary artery disease. The number of patients with hypercholesterolemia has been increasing in recent decades, possibly because of the growing obese population. In the first six months after diagnosis of hypercholesterolemia, 40% of patients with hypercholesterolemia die. This percentage is higher for patients with severe hypercholesterolemia. Early detection and risk factor correction can prevent the progression of coronary artery disease and decrease atherosclerotic complications.

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What is the latest research for hypercholesterolemia?

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This paper is a summary of the current literature on hypercholesterolemia, with emphasis on the most recent research. The emphasis is on lipid profiles as well as treatment modalities and lipid profiles will be discussed.

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Does hypercholesterolemia run in families?

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Recent findings do not demonstrate an increase in LDL-C levels in FH families, when compared to healthy control and FH families and with controls; therefore, there is no support for the hypothesis that a non-familial clustering of these conditions exists in that population.

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What are the latest developments in lerodalcibep for therapeutic use?

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Lerodalcibep is a non-steroidal anti-inflammatory drug currently in use in clinical trials as a therapeutic option for the treatment of osteoarthritis of the knee with proven efficacy and safety demonstrated in Phase III trial. The Phase II Study confirmed the effect observed in Phase III Clinical study showing a consistent improvement in both clinical scores and function of osteo(arthritis) of the knee.

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