lerodalcibep for Hyperlipoproteinemia Type II

Phase-Based Estimates
2
Effectiveness
3
Safety
Rabin Medical Center, Beilinson Hospital,, Petah Tikva, Israel
Hyperlipoproteinemia Type II+6 More
lerodalcibep - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Hyperlipoproteinemia Type II

Study Summary

This study is evaluating whether a drug called LIB003 is safe and effective for people with high cholesterol.

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Eligible Conditions

  • Hyperlipoproteinemia Type II
  • Hypercholesterolemia
  • Cardiovascular Diseases
  • Arteriosclerosis
  • elevations of serum cholesterol
  • Cardiovascular Disease With Mention of Arteriosclerosis
  • Primary Hypercholesterolemia

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 1 primary outcome and 2 secondary outcomes in patients with Hyperlipoproteinemia Type II. Measurement will happen over the course of 72 weeks.

72 weeks
Immunogenicity
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks
LDL Cholesterol reduction

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Control
LIB003 (lerodalcibep)

This trial requires 2000 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. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

LIB003 (lerodalcibep)
Drug
300 mg monthly (Q4W) by subcutaneous injection
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 72 weeks for reporting.

Closest Location

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

Eligibility Criteria

This trial is for patients born any sex of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female patients who may become pregnant must use a birth control method that is highly effective if sexually active and have a negative pregnancy test on Day 1 prior to taking the medication. show original
Subjects who complete one of the Phase 3 base studies without any Serious Adverse Events related to the study drug, or who provide written and signed informed consent prior to any study-specific procedure, are eligible to participate in the Phase 3 safety extension study. show original
The patient is willing to continue following a healthy diet and taking their current lipid-lowering medications, including statins, ezetimibe, bile acid sequestrants, niacin, bempedoic acid, bezafibrate or fenofibrate, and/or OM-3 compounds. show original
The patient is healthy, according to the investigator. 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.

Who should consider clinical trials for hyperlipoproteinemia type ii?

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Patients with hyperlipoproteinemia type II must be assessed based on the type of genetic mutation. In patients with two or more lipid-associated gene mutations, they may benefit from lipid-controlling therapy. In patients with only a single lipid-associated gene mutation, their chances for response to lipid-controlling therapy are lower than those with two mutations, and they must be assessed based on clinical experience. Only a few medications are available for hyperlipoproteinemia type II; thus, most patients with this disease benefit from lipid-controlling drugs, such as statins.

Unverified Answer

What is hyperlipoproteinemia type ii?

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Hyperlipoproteinemia type ii is a familial genetic trait characterized by very low levels of LDL receptors in the patient's serum. The deficiency of LDL receptors prevents LDL absorption from the blood into the tissues and prevents the patient's cells from converting circulating HDL"lipoprotein" to the LDL forms. This defective metabolism may also be associated with the progressive atherosclerosis observed in these families.

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What are common treatments for hyperlipoproteinemia type ii?

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The current analysis provides a comparison of available treatments in order to identify the one that is most effective for the treatment of patients suffering from hyperlipoproteinemia type ii.

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How many people get hyperlipoproteinemia type ii a year in the United States?

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Results from a recent paper suggest that the majority of families seeking medical help for their children with hyperlipoproteinemia type ii do not have the condition in their family. This indicates that one of the reasons for screening families for hyperlipoproteinemia type ii is not familial aggregation.

Unverified Answer

What causes hyperlipoproteinemia type ii?

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We have used an updated approach to classify hyperlipoproteemias. A new classification system is expected to provide clues to pathogeneses and will identify patients with different clinical and genetic characteristics.

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What are the signs of hyperlipoproteinemia type ii?

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Hyperlipoproteinemia type ii is associated with a low-density lipoprotein receptor. Its clinical presentation varies widely depending on cholesterol levels. These are largely determined by the genetic make-up of the individual. Hyperlipoproteinemia type ii is a heterogeneous heterogeneous disorder and requires a comprehensive diagnostic approach, which should include cholesterol, triglyceride and other lipid testing and LDL-receptor genotyping.

Unverified Answer

Can hyperlipoproteinemia type ii be cured?

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Hyperlipoproteinemia type II is caused by a defect in the lipase enzyme. However, patients with a single gene mutation (PALB2) have no lipid abnormalities. Thus, even though a defect in the PALB2 gene is responsible for hyperlipoproteinemia type II, the disease is not curable.

Unverified Answer

Have there been other clinical trials involving lerodalcibep?

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We can now conclude that Lerodalcibep is effective in improving serum lipids and reducing liver iron overload in patients with HVPGL-II and NCP. Further, our results support Lerodalcibep as a reliable, well- tolerated treatment for patients with HVPGL-II and NCP.

Unverified Answer

Has lerodalcibep proven to be more effective than a placebo?

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Considering the available evidence, the results do not support the use of lerodalcibep in the treatment of patients with primary hypercholesterolemia. There were no serious adverse events of treatment. Furthermore, no significant difference in safety and efficacy between the groups was observed.

Unverified Answer

What is the average age someone gets hyperlipoproteinemia type ii?

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Hyperlipoproteinemia type ii is a condition that occurs mostly in young adults and can result in many different kinds of health problems due to high cholesterol. If you get a sample from someone, [Power] will let you know if that person is over the average age for hyperlipoproteinemia type ii for their age group.

Unverified Answer

Is lerodalcibep typically used in combination with any other treatments?

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In most cases, Lerodalcibep is usually used in conjunction with other agents in the treatment of FOP-MFS patients. However, the optimal treatment combining Lerodalcibep with other therapy or agents is still in question and requires careful monitoring to ensure an optimal clinical outcome.

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How does lerodalcibep work?

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Lerodalcibep has proven effective in Phase II clinical trials in systemic lupus erythematosus, chronic phase chronic hepatitis C and myelodysplastic syndrome. The mechanism of action is not entirely clear at this time. Whether it has a different mode of action from that of alfacalcidol or other bivalent calcium channel blockers is not known though the drug inhibits calcium-dependent exocytosis, the process of releasing the lipid-containing particles containing cell membrane and lysosome inclusions known as secretory phospholipase A2.

Unverified Answer
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