#1 Clinical Trials Search in Europe

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 how well the treatment works and how safe it is, with outcomes such as LDL cholesterol and other blood markers. All listed trials are Phase 3 studies.

Table of Contents

Overview of the clinical trials

Three interventional Phase 3 trials are listed for Alirocumab, and each one studies a different patient group and research question.[1][2][3] Interventional means the researchers assign a treatment or comparison group rather than only observing what happens.[1]

Recent heart transplant recipients

One completed Phase 3 study looked at recent heart transplant recipients and early cardiac allograft vasculopathy, which is a blood vessel problem that can affect the transplanted heart.[1] The trial tested Alirocumab against placebo while participants also received standard background lipid-lowering therapy with atorvastatin 10 mg daily.[1]

The main goal was to assess whether Alirocumab could lower LDL cholesterol in the first 1 to 12 months after heart transplantation.[1] The study also measured other blood fat markers, including total cholesterol, HDL-C, ApoA1, ApoB, lipoprotein(a), and triglycerides at several treatment visits.[1]

Hyperlipidemia and hormone-related outcomes

Another authorised Phase 3 trial studied people with hyperlipidemia, which means high levels of fats in the blood.[2] This study asked whether cholesterol-lowering drugs, including Alirocumab, change sex steroid levels, which are hormone levels related to sex hormones.[2]

The trial included Alirocumab as one of several treatments being compared, along with other lipid-lowering medicines such as rosuvastatin, atorvastatin, evolocumab, and inclisiran.[2] Its primary outcome was changes in sex steroid levels, so the study is not only about cholesterol numbers but also about possible effects on hormone-related blood markers.[2]

Pediatric heterozygous familial hypercholesterolemia

A third authorised Phase 3 trial is the head-to-head PICOLO-FH study in children and adolescents with heterozygous familial hypercholesterolemia, an inherited condition that causes high cholesterol.[3] The study compares Alirocumab plus rosuvastatin, inclisiran plus rosuvastatin, and standard rosuvastatin therapy.[3]

The main endpoint is whether participants reach an LDL-C target of less than 100 mg/dl after 104 weeks of treatment.[3] This makes the study a long-term comparison of how well the treatment strategies help children reach a clear cholesterol goal.[3]

Main endpoints and what they mean

Primary endpoint means the main result the researchers plan to measure.[1][2][3] In the heart transplant study, the primary endpoint is a set of lipid measurements, including LDL-C, HDL-C, total cholesterol, triglycerides, ApoB, Lp(a), and ApoA1.[1]

In the hyperlipidemia study, the primary endpoint is the change in sex steroid levels.[2] In the pediatric familial hypercholesterolemia study, the primary endpoint is the number and percentage of participants who achieve LDL-C below 100 mg/dl after 104 weeks.[3]

Trial design, phases, and enrollment

All three studies are Phase 3 trials, which means they are larger studies meant to better understand treatment effects in real patient groups.[1][2][3] The completed heart transplant study enrolled 126 participants, the hyperlipidemia study plans 250 participants, and the pediatric familial hypercholesterolemia study plans 400 participants.[1][2][3]

The studies differ in status as well: one is completed, and two are authorised.[1][2][3] Together, they show that Alirocumab is being studied in both adult and pediatric settings, as well as in a special post-transplant group.[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 is being studied in Alirocumab clinical trials? The trials include recent heart transplant recipients, people with hyperlipidemia, and children with heterozygous familial hypercholesterolemia. Each study focuses on a different patient group.
  • What are the main goals of these trials? The main goals are to see whether Alirocumab helps improve blood cholesterol results and other related markers. One trial also studies safety after heart transplant.
  • What phase are the Alirocumab trials in? All three trials listed are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups to learn more about its effects.
  • What conditions are being studied? The trials study cardiac allograft vasculopathy after heart transplant, hyperlipidemia, and heterozygous familial hypercholesterolemia. These are conditions linked to abnormal blood fats or heart transplant care.
  • What kinds of results are measured in these studies? The studies measure LDL-C and other lipid markers such as HDL-C, total cholesterol, triglycerides, ApoB, Lp(a), and ApoA1. One pediatric trial also measures whether participants reach a target LDL-C level after 104 weeks.

Ongoing Clinical Trials on Alirocumab

  • Study on Inclisiran, Alirocumab, and Rosuvastatin for Children with Familial Hypercholesterolemia

    Recruiting

    3 1 1 1
    Investigated drugs:
    Poland

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

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria

  • Study on Alirocumab for Preventing Heart Vessel Disease in Recent Heart Transplant Patients

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Czechia

References

  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