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

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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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

3 criteria

  • 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.
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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.

What is already known about the treatment

Cholesterol-lowering drugs – These medications are typically taken orally in the form of tablets or capsules. They are widely used in medicine to manage high cholesterol levels, a condition known as hyperlipidemia. The primary purpose of these drugs is to lower cholesterol levels in the blood, which can help prevent heart disease and other related conditions. At the molecular level, they work by inhibiting an enzyme in the liver that is responsible for producing cholesterol, thereby reducing its overall levels in the body. These drugs are classified as lipid-lowering agents and are an essential part of treatment plans for individuals with high cholesterol.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516967-10-00Protocol codeCHORMONEEstimated enrolment250 patientsSponsorMedical University Of Vienna

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).