lerodalcibep for Cardiovascular Diseases

Phase-Based Estimates
2
Effectiveness
3
Safety
Sterling Research Group, Cincinnati, OH
Cardiovascular Diseases+1 More
lerodalcibep - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cardiovascular Diseases

Study Summary

This study is evaluating whether a drug called lerodalcibep can lower cholesterol levels.

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Eligible Conditions

  • Cardiovascular Diseases
  • Hyper-LDL-cholesterolemia

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 Cardiovascular Diseases. Measurement will happen over the course of 52 weeks.

52 weeks
Free PCSK9 change
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
mean LDL-C change at week 50 and 52

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Placebo
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)
Drug
300 mg subcutaneously monthly (Q4W)
Placebo
Drug
matching placebo subcutaneously monthly (Q4W)

Trial Logistics

Trial Timeline

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

Closest Location

Sterling Research Group - 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:
At Screening or post Washout/Stabilization), ≥70 mg/dL and TG ≤400 mg/dL while on stable lipid-lowering oral drug therapy (i.e., maximally tolerated statin with or without ezetimibe); Patients unable to tolerate approved doses of a statin may take lower than approved doses and dose less frequently than daily as long as the dose and dosing frequency is consistent; Patients with documentation of inability to tolerate any statin at any dose, or history of rhabdomyolysis, may also participate;
Provision of written and signed informed consent prior to any study-specific procedure;
Male or female ≥18 years of age at the first Screening Visit;
Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2;
At very high risk for CVD which includes history of CVD, (including cerebrovascular or peripheral arterial disease) or very high risk as defined in the 2019 ESC/EAS Guidelines
On a stable diet and lipid-lowering oral therapies (such as statins, ezetimibe, bile-acid sequestrants, OM-3 compounds, fenofibrate, bezafibrate, nicotinic acid, and bempedoic acid) or combinations thereof for at least 4 weeks
Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥4 weeks after the last dose; for those on 300 mg or 420 mg Q4W (≤31 days) the washout period is ≥8 weeks following last dose; 8. 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 cardiovascular diseases be cured?

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In a recent study, findings do not justify the term "cure" as it has often been construed. The present approach may have a role in reducing CVD incidence and, perhaps more importantly, mortality, especially early in the course of the disease, or at the earliest stages of disease where prevention of complications and disease progression would have the greatest impact.

Unverified Answer

What are the signs of cardiovascular diseases?

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Symptoms of acute cardiac events may not be as simple as one might expect. Physicians should have ready access to information about major symptomatology of cardiovascular diseases, so clinicians can better inform patients and their families of their risk factors for these conditions.

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What causes cardiovascular diseases?

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The current medical theories do not completely explain the complex interactions between environmental factors and genetic predispositions associated with CVD, and there remains a need for a greater understanding of how individual factors, both behavioral and genetic, contribute to this endgame. Future research is needed into how the interaction between these factors may play an important, causal role in the development of CVD.

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How many people get cardiovascular diseases a year in the United States?

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It is estimated that approximately 26 million people will be diagnosed with a cardiovascular disease in the year 2013. This estimation represents around 18% of American adults.

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What is cardiovascular diseases?

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The prevalence of cardiovascular disease (CVDs) is a major health concern. CVDs is the leading cause of death in the USA, and its financial burden is enormous. There is a need for a targeted and rigorous approach to prevent CVDs.

Unverified Answer

What are common treatments for cardiovascular diseases?

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A variety of treatments may be used for cardiovascular diseases. The aim of medical treatment is to reduce symptoms and improve patient's functioning and quality of life.

Unverified Answer

Does lerodalcibep improve quality of life for those with cardiovascular diseases?

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Improvements in physical function are seen. Significant and clinically meaningful improvements in most HRQL dimensions have also been observed, and these improvements appear to be maintained over a 1-year post-intervention period. Recent findings of the ACTIS trial provide preliminary evidence that lerodalcibep can improve HRQL, and confirm that its use can improve physical function and reduce pain in patients with stable ischemic heart disease. Further prospective, well-designed, multi-center studies are now needed.

Unverified Answer

What is the average age someone gets cardiovascular diseases?

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Approximately 1 in 3 men have some forms of cardiovascular disease by the age of 70, which is significantly older than the median age at death for all Americans. The most prevalent of these diseases are heart disease and stroke; the 2 main causes of cardiovascular disease death in Americans aged 65-74, accounting for more than half of all mortality in this age bracket. A significant portion of this excess mortality is attributable to heart failure, for which a single treatment may dramatically affect patient outcome.

Unverified Answer

Is lerodalcibep typically used in combination with any other treatments?

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Lerodalcibep showed satisfactory efficacy and tolerability. The combination with conventional nonsteroidal anti-inflammatory drugs or warfarin is reasonable. More subjects should receive a longer treatment with lerodalcibep and have a longer observation periods to assess the duration of such treatment in the future.

Unverified Answer

Does cardiovascular diseases run in families?

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Findings from a recent study has identified novel genetic variants in the CARD8 gene encoding NAD(P)H oxidase 2 and has revealed the strong evidence of genetic influence of CARD8 on the risk for both CAD and MI in the general population. We have also shown that the CARD8 variants identified in this study are associated with the occurrence of myocardial infarction in male subjects.

Unverified Answer

Who should consider clinical trials for cardiovascular diseases?

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A great many high quality studies are underway for evaluating clinical trials. However, a systematic search of the literature may limit the number of clinical trials that could be conducted in the future. For clinical trials aiming at assessing treatment interventions for a specific condition, we suggested that clinicians, researchers, and policy-makers should work together to identify appropriate clinical trials, and they should establish eligibility criteria that would reduce the likelihood of selecting for the trials in which interventions will be ineffective or dangerous.

Unverified Answer

What are the latest developments in lerodalcibep for therapeutic use?

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Lerodalcibep is being evaluated for the therapeutic use of reducing or preventing excessive calcium absorption in individuals with hypercalciuria. One of the indications includes, but is not limited to, the treatment of primary hyperparathyroidism. Further clinical studies will support this application. In patients with familial hyperparathyroidism, lerodalcibep has been evaluated in patients who have had a calcium-sparing parathyroidectomy. Lerodalcibep appears to be effective in mitigating recurrent renal stones, and it appears to have a lower rate of side effects than many other therapies used in this indication. Overall, future studies will likely clarify these preliminary findings.

Unverified Answer
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