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Study on Long-Term Effects of Lerodalcibep for Lowering Cholesterol in Patients with Familial Hypercholesterolemia or Cardiovascular Disease Risks

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of an investigational drug called Lerodalcibep, also known by its code name LIB003. The study is designed for patients with certain types of high cholesterol, specifically those with Homozygous and Heterozygous Familial Hypercholesterolemia, as well as individuals with Cardiovascular Disease or those at high risk for such diseases. These conditions are characterized by high levels of cholesterol in the blood, which can lead to heart problems. The treatment involves a solution for injection that is administered under the skin.

The purpose of the study is to evaluate the long-term safety and effectiveness of Lerodalcibep in reducing cholesterol levels. Participants in the study will receive the drug once a month for a period of up to 72 weeks. The study aims to see how well the drug works in lowering cholesterol levels and to monitor any side effects that may occur over time. Patients involved in the study will continue their current cholesterol-lowering treatments while receiving the investigational drug.

Throughout the study, participants will have regular check-ups to assess their health and the impact of the treatment. This includes monitoring cholesterol levels and other health indicators to ensure the safety and effectiveness of the drug. The study is an extension of previous research and includes patients who have already participated in earlier phases of the trial. The goal is to provide additional information on how Lerodalcibep can help manage cholesterol levels in patients with high cardiovascular risk.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have completed a previous Phase 3 study with the investigational drug LIB003 and have no serious adverse events related to the drug.
The patient must provide written and signed informed consent before any study-specific procedures begin.
Step 2
Initial assessment
An initial assessment is conducted to ensure the patient is otherwise healthy. This includes a review of medical history, a complete physical examination, vital sign measurements, electrocardiograms (ECGs), and laboratory test results.
Step 3
Medication administration
The patient receives LIB003, a solution for injection, administered subcutaneously (under the skin) at a dose of 300 mg every four weeks (monthly).
The treatment continues for a duration of 72 weeks.
Step 4
Ongoing assessments
Throughout the study, the patient undergoes regular assessments to monitor the efficacy and safety of the treatment.
These assessments include measuring changes in cholesterol levels and other serum lipids at Weeks 48 and 72, as well as monitoring for any adverse effects.
Step 5
Final evaluation
At the end of the study period, a final evaluation is conducted to assess the long-term safety and efficacy of the treatment.
This includes measuring the presence of any anti-LIB003 antibodies and the pharmacokinetic concentration of LIB003.

Who can join the trial?

7 criteria

The patient must have completed a previous study with the study drug and had a final visit without any serious side effects related to the drug.
The patient must provide written and signed consent before any study-related procedures begin.
Female patients who can have children must use a **highly effective form of birth control** if they are sexually active and must have a negative pregnancy test before starting the study. Birth control methods include birth control pills, patches, intrauterine devices (IUDs), or having a partner who has had a vasectomy. Women who are postmenopausal or have been sterilized are not considered to be able to have children.
Male patients must either be surgically sterile or agree to use contraception if their partner can have children and is not using a highly effective form of birth control. This includes using condoms with spermicide or having a partner who uses contraceptives like IUDs or birth control pills.
Male patients must not donate sperm until 90 days after the last dose of the study drug.
The patient must be willing to maintain a proper diet and continue their current **lipid-lowering therapy (LLT)**, which includes medications like statins, ezetimibe, and others. Some patients may also need a procedure called **apheresis** after 12 weeks.
The patient must be considered healthy by the study doctor, based on their medical history, physical examination, vital signs, heart tests (ECGs), and laboratory test results from the previous study.

Who cannot join the trial?

6 criteria

Patients who have not completed a previous LIB003 Phase 3 base study.
Patients who are not on a stable diet and maximally tolerated oral LDL-C lowering drug therapy. **LDL-C** refers to "bad" cholesterol that can build up in the walls of your arteries.
Patients who are not at very-high risk or high risk for **cardiovascular disease**. This means they do not have a high chance of having heart-related problems.
Patients who do not have **Homozygous Familial Hypercholesterolemia (HoFH)** or **Heterozygous Familial Hypercholesterolemia (HeFH)**. These are genetic conditions that cause very high cholesterol levels.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population that the study does not include.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Verified
Centre Hospitalier Universitaire De Dijon
Dijon, France

Trial locations

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Investigated drugs

LIB003 is a medication being studied for its ability to lower low-density lipoprotein cholesterol (LDL-C) in patients with familial hypercholesterolemia or those at high risk for cardiovascular disease. It is administered through an injection under the skin. The study aims to evaluate the long-term safety and effectiveness of this medication when given once a month.

Lerodalcibep

What is already known about the treatment

LIB003 – This medication is administered through a subcutaneous injection, typically given once a month. It is currently being studied in clinical trials to evaluate its long-term safety and effectiveness for patients with familial hypercholesterolemia and those at high risk for cardiovascular disease. The main therapeutic use of LIB003 is to further reduce low-density lipoprotein cholesterol (LDL-C) levels in patients already on stable lipid-lowering therapy. At the molecular level, LIB003 works by inhibiting a specific protein involved in cholesterol regulation, thereby lowering LDL-C levels in the blood. It is classified as a lipid-lowering agent.

Investigated diseases

Homozygous Familial Hypercholesterolemia
This is a genetic disorder characterized by extremely high levels of low-density lipoprotein cholesterol (LDL-C) in the blood. It occurs when both parents pass on a defective gene that affects the body's ability to remove LDL-C. As a result, cholesterol builds up in the blood, leading to early onset of cardiovascular disease. Individuals with this condition may develop cholesterol deposits in the skin and tendons. The disease progresses rapidly, often leading to heart problems at a young age.
Heterozygous Familial Hypercholesterolemia
This genetic condition results in high levels of LDL cholesterol due to a single defective gene inherited from one parent. It is less severe than the homozygous form but still significantly increases the risk of cardiovascular disease. People with this condition may not show symptoms until adulthood. Over time, the elevated cholesterol levels can lead to the development of atherosclerosis. This can cause narrowing and hardening of the arteries, potentially leading to heart attacks or strokes.
Cardiovascular Disease
This term encompasses a range of conditions affecting the heart and blood vessels. It includes diseases such as coronary artery disease, heart failure, and arrhythmias. These conditions often develop due to atherosclerosis, where plaque builds up in the arteries, restricting blood flow. Over time, this can lead to chest pain, heart attacks, or strokes. Risk factors include high blood pressure, high cholesterol, smoking, and diabetes. Cardiovascular disease can progress silently, often without symptoms until a significant event occurs.