Study on the Effects of Alirocumab and Drug Combination on Hyperlipidemia in Patients

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What is this study about?

This clinical trial is focused on studying the effects of cholesterol-lowering drugs on various aspects of health, including their relationship with steroid hormones, bile acids, muscle morphology (the structure of muscles), vitamin D, the immune system, and related conditions such as depression and osteoporosis. The main goal is to determine if these medications can reduce the levels of steroid hormones in the body. The diseases being studied include hyperlipidemia, which is a condition characterized by high levels of lipids (fats) in the blood.

The trial involves several cholesterol-lowering medications, including alirocumab, rosuvastatin, evolocumab, atorvastatin, and inclisiran. These medications are used to help manage cholesterol levels and are administered in different forms, such as tablets or injections. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

Participants in the study will be monitored over a period of up to 36 months. During this time, they will receive one of the cholesterol-lowering medications or a placebo. The study will observe changes in the levels of sex steroids, which are hormones that play a role in sexual development and reproduction. The trial aims to provide valuable insights into how these medications might affect various bodily functions and conditions related to cholesterol management.

1 initial visit

Upon joining the clinical trial, you will attend an initial visit. During this visit, your eligibility will be confirmed based on your age and cholesterol levels. You will be asked about your medical history and any previous treatments for high cholesterol.

If you are eligible, you will receive detailed information about the trial, including the medications involved and the schedule of visits and tests.

2 medication administration

You will be assigned a specific medication regimen based on your group in the trial. The medications used in this trial include alirocumab, rosuvastatin, evolocumab, atorvastatin, and inclisiran.

Some medications are taken orally, such as rosuvastatin and atorvastatin, while others are administered through subcutaneous injection, like alirocumab, evolocumab, and inclisiran.

3 regular follow-up visits

You will attend regular follow-up visits to monitor your health and the effects of the medication. These visits will include blood tests to measure cholesterol levels and other health indicators.

The frequency of these visits will be explained to you during the initial visit, and it is important to attend all scheduled appointments.

4 end of trial assessment

At the end of the trial, you will undergo a final assessment. This will include a comprehensive evaluation of your health and any changes in your cholesterol levels and other related health markers.

The results of the trial will be shared with you, and you will have the opportunity to discuss any questions or concerns with the trial team.

Who Can Join the Study?

Age between 18 and 75 years old.
LDL cholesterol levels greater than 116 mg/dl. LDL cholesterol is often called “bad” cholesterol because high levels can lead to health problems.
For most participants: Must have been previously prescribed treatment for dyslipidemia (an abnormal amount of lipids in the blood) following specific guidelines. This includes taking either atorvastatin at a dose of 40 mg or more, rosuvastatin at a dose of 20 mg or more, or using PCSK-9 inhibitors like Praluent, Repatha, or Inclisiran. PCSK-9 inhibitors are a type of medication that helps lower cholesterol levels.
For participants new to low-dose statin therapy: No history of taking statins (a type of medication used to lower cholesterol). Must have been previously prescribed treatment for dyslipidemia following specific guidelines, with simvastatin at a dose of 20 mg or less, atorvastatin at a dose of 10 mg or less, or rosuvastatin at a dose of 10 mg or less.

Who Cannot Join the Study?

Patients with hyperlipidemia (high levels of fats like cholesterol in the blood) cannot participate.
Individuals outside the age range of 18 to 65 years are excluded.
Participants who are part of vulnerable populations, such as those unable to give consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Cholesterol-lowering drugs are medications used to reduce the levels of cholesterol in the blood. High cholesterol can lead to heart disease and other health problems. These drugs work by blocking a substance your body needs to make cholesterol, which can help prevent heart attacks and strokes. In this trial, researchers are studying how these drugs might also affect other parts of the body, like hormone levels, muscle health, and the immune system.

Hyperlipidemia – Hyperlipidemia is a condition characterized by elevated levels of lipids, such as cholesterol and triglycerides, in the blood. Over time, these excess lipids can accumulate on the walls of arteries, leading to atherosclerosis, which is the hardening and narrowing of the arteries. This process can progress silently without symptoms for many years. As the condition advances, it may contribute to the development of cardiovascular diseases. The progression of hyperlipidemia is influenced by factors such as diet, lifestyle, and genetics. Regular monitoring of blood lipid levels is important to understand its progression.

Trial ID:

2024-516967-10-00

Protocol code:

CHORMONE

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Alirocumab and Drug Combination on Hyperlipidemia in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?