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Alirocumab

Clinical trials are investigating Alirocumab in different patient groups, including recent heart transplant recipients, people with hyperlipidemia, and children with heterozygous familial hypercholesterolemia. These studies look at whether it helps reach lipid goals and how it affects safety and other health measures.

Table of contents

Overview of the clinical research

The trials listed for Alirocumab are all interventional studies, which means researchers give a treatment and compare the results with another treatment or placebo.[1][2][3] All three studies are in Phase 3, so they are testing the treatment in larger groups of people with specific conditions.[1][2][3] The research focuses on cholesterol-related problems and one transplant-related complication.[1][2][3]

Recent heart transplant recipients

One completed study looked at the efficacy and safety of Alirocumab to prevent early cardiac allograft vasculopathy in recent heart transplant recipients.[1] Cardiac allograft vasculopathy is a problem that affects the blood vessels of a transplanted heart.[1] The study included 126 participants and followed them during the first 1 to 12 months after heart transplantation.[1]

This trial compared Alirocumab with a placebo product for REGN727, while participants also received background lipid-lowering therapy with atorvastatin 10 mg daily.[1] The main goal was to assess the mean levels of LDL-C, HDL-C, total cholesterol, triglycerides, ApoB, lipoprotein(a), and ApoA1 at several treatment visits.[1] This means the study was not only looking at one cholesterol value, but at a full lipid profile, which is a group of blood fat measurements.[1]

Hyperlipidemia and related body measures

Another Phase 3 study is authorised in people with hyperlipidemia, which means high levels of fats such as cholesterol in the blood.[2] The brief summary asks whether cholesterol-lowering drugs reduce the levels of steroid hormones.[2] In this study, Alirocumab is one of several treatments being compared with other lipid-lowering drugs, including rosuvastatin, atorvastatin, evolocumab, and inclisiran.[2]

The primary outcome is changes in sex steroid levels.[2] This means the researchers are checking whether treatment changes hormone levels that are made from cholesterol and that play a role in body functions such as reproduction and other hormone-related processes.[2] The study has an enrollment of 250 participants.[2]

Pediatric heterozygous familial hypercholesterolemia

A third Phase 3 study is authorised in children with heterozygous familial hypercholesterolemia, a genetic condition that causes very high cholesterol levels.[3] This trial is called the head-to-head PICOLO-FH clinical trial, which means it directly compares one treatment approach with another.[3] The study compares inclisiran or Alirocumab with standard therapy using rosuvastatin.[3]

The trial includes 400 participants and tests Alirocumab at two listed doses, 300 mg and 150 mg, both given by subcutaneous injection.[3] The main endpoint is the number and percentage of participants who reach the goal of LDL-C below 100 mg/dl after 104 weeks of treatment.[3] This is a practical target because it measures whether treatment helps children reach a defined cholesterol goal over a long follow-up period.[3]

Main endpoints and what they mean

The primary endpoint is the main result a trial is designed to measure.[1][2][3] In the transplant study, the primary endpoint is a set of lipid values measured at treatment visits, including LDL-C, HDL-C, total cholesterol, triglycerides, ApoB, lipoprotein(a), and ApoA1.[1] In the hormone study, the primary endpoint is the change in sex steroid levels.[2] In the pediatric study, the primary endpoint is how many participants achieve LDL-C under 100 mg/dl after 104 weeks.[3]

These endpoints show that the trials are focused on different but related questions.[1][2][3] One study looks at transplant protection and lipid control, one looks at possible hormone effects, and one looks at long-term cholesterol goal achievement in children.[1][2][3]

Study design, phases, and participation

All three studies are Phase 3 and are designed to compare Alirocumab with other treatments or placebo in specific patient groups.[1][2][3] The completed transplant study enrolled 126 people, the hormone study plans 250, and the pediatric familial hypercholesterolemia study plans 400.[1][2][3] Together, these trials show that Alirocumab is being studied in both adult and pediatric populations, with different health goals and follow-up periods.[1][2][3]

Because each trial has its own condition, treatment plan, and outcome measure, participation would depend on the specific study rules for that trial.[1][2][3] The source data does not provide full eligibility criteria, so only the target populations listed above can be confirmed from these trial records.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2024-514023-42-00 Phase 3 Cardiac allograft vasculopathy in recent heart transplant recipients Completed 126
2024-516967-10-00 Phase 3 Hyperlipidemia Authorised 250
2024-514523-42-00 Phase 3 Heterozygous familial hypercholesterolemia Authorised 400

FAQ

  • Who can take part in Alirocumab clinical trials? The trials described include recent heart transplant recipients, people with hyperlipidemia, and children with heterozygous familial hypercholesterolemia. Each study has its own entry rules based on the condition being studied.
  • What are the trials studying? They are studying whether Alirocumab helps improve blood lipid levels and reach treatment goals. One trial also looks at early cardiac allograft vasculopathy after heart transplant, and another looks at possible effects on steroid hormones and related health measures.
  • What phases are these Alirocumab trials? All three trials listed are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups to learn more about how well it works and how safe it is.
  • What conditions are being studied with Alirocumab? The conditions include early cardiac allograft vasculopathy in recent heart transplant recipients, hyperlipidemia, and heterozygous familial hypercholesterolemia in children. These are all conditions linked to abnormal cholesterol or lipid levels.
  • What outcomes are measured in these trials? The trials measure lipid results such as LDL-C, HDL-C, total cholesterol, triglycerides, ApoB, ApoA1, and lipoprotein(a). One pediatric trial also measures whether participants reach LDL-C below 100 mg/dl after 104 weeks.

Sperimentazioni cliniche in corso su Alirocumab

  • Studio sull’efficacia di Inclisiran, Alirocumab e Rosuvastatina nei bambini con ipercolesterolemia familiare eterozigote

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Polonia

  • Studio sull’effetto di Alirocumab e combinazione di farmaci su ormoni steroidei in pazienti con iperlipidemia

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Austria

  • Studio sull’efficacia e sicurezza di alirocumab per prevenire la vasculopatia del trapianto cardiaco in pazienti recentemente sottoposti a trapianto di cuore

    Arruolamento concluso

    1 1
    Malattie in studio:
    Farmaci in studio:
    Cechia

Glossario

  • Alirocumab: The study treatment being tested in these trials.
  • Phase 3: A late stage of clinical research where a treatment is tested in larger groups of people.
  • Interventional trial: A study where researchers give a treatment and compare results with another treatment or placebo.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.
  • Heart transplant recipient: A person who has received a new heart through transplant surgery.
  • Cardiac allograft vasculopathy: A problem affecting the blood vessels of a transplanted heart.
  • Hyperlipidemia: A condition with too much fat, such as cholesterol, in the blood.
  • Heterozygous familial hypercholesterolemia: An inherited condition that causes very high cholesterol levels.
  • LDL-C: Low-density lipoprotein cholesterol, often called 'bad cholesterol'.
  • HDL-C: High-density lipoprotein cholesterol, often called 'good cholesterol'.
  • ApoB: A blood marker linked to particles that carry cholesterol.
  • Lipoprotein(a): A type of blood fat linked to cardiovascular risk.

Riferimenti

  1. https://clinicaltrials.gov/study/2024-514023-42-00
  2. https://clinicaltrials.gov/study/2024-516967-10-00
  3. https://clinicaltrials.gov/study/2024-514523-42-00