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Study on the Effects of Roxadustat and Placebo on Cardiovascular Risk Factors and Metabolic Syndrome in Patients

Registered drugNo 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 a medication called Evrenzo, which contains the active substance roxadustat. The study is aimed at individuals with risk factors for cardiovascular disease and those with metabolic syndrome. Metabolic syndrome is a group of conditions that occur together, increasing the risk of heart disease, stroke, and type 2 diabetes. The purpose of the study is to explore how roxadustat affects glucose and lipid metabolism, as well as cardiovascular function.

Participants in the study will receive either the active medication, Evrenzo, or a placebo, which looks like the medication but does not contain the active substance. The study will last for a period of eight weeks, during which participants will take the medication orally in the form of film-coated tablets. Throughout the study, various health parameters will be monitored, including cholesterol levels, insulin resistance, glucose tolerance, body composition, blood pressure, and muscle blood flow.

The trial aims to provide insights into how roxadustat can influence factors related to heart health and metabolism. By understanding these effects, researchers hope to contribute to better management of conditions associated with cardiovascular disease and metabolic syndrome. The study is expected to conclude by the end of 2025.

The research process

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

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, a comprehensive review of your medical history is conducted. A physical examination and laboratory tests are performed to ensure good general health.

    A 12-lead ECG, which is a test that records the electrical activity of the heart, is also conducted. This helps in assessing your eligibility for the trial.

  2. Step 2

    Randomization and medication

    After confirming eligibility, you are randomly assigned to receive either the placebo or Evrenzo 70 mg film-coated tablets containing roxadustat. This is done to compare the effects of the medication with no active treatment.

    The medication is taken orally in the form of a film-coated tablet. The dosage and frequency of administration are determined by the study protocol and communicated to you by the study team.

  3. Step 3

    Regular follow-up visits

    Throughout the trial, regular follow-up visits are scheduled. These visits are essential for monitoring your health and the effects of the medication.

    During these visits, blood samples are taken to measure plasma total cholesterol levels, plasma LDL cholesterol and triglyceride levels, and other markers related to glucose and lipid metabolism.

  4. Step 4

    Monitoring and assessments

    Additional assessments include evaluating insulin resistance and glucose tolerance, body composition, blood pressure, and skeletal muscle microcirculation.

    These assessments help in understanding the impact of the medication on various aspects of your health.

  5. Step 5

    End of trial

    The trial is expected to conclude by December 31, 2025. At the end of the trial, a final visit is conducted to assess your overall health and gather final data.

    The results of the trial will contribute to understanding the effects of roxadustat on cardiometabolism.

Who can join the trial?

4 criteria

  • Body mass index (BMI) over 20 kg/m2 and body weight below 100 kg. Body mass index is a measure that uses your height and weight to work out if your weight is healthy.
  • Good general health based on the results of medical history, laboratory tests, physical examination, and 12-lead ECG as assessed by the investigator. A 12-lead ECG is a test that records the electrical activity of the heart to check for different heart conditions.
  • Both males and females can participate.
  • Participants should not be from a vulnerable population.

Who cannot join the trial?

10 criteria

  • Patients with a history of **heart disease** or **stroke** cannot participate.
  • Individuals with **uncontrolled high blood pressure** are excluded. This means if your blood pressure is not managed well with medication or lifestyle changes, you cannot join.
  • People with **severe liver disease** are not eligible. This refers to serious liver problems that affect its function.
  • Those with **kidney disease** requiring dialysis cannot take part. Dialysis is a treatment that does the work of your kidneys if they are not functioning properly.
  • Participants with **active cancer** are excluded. Active cancer means you are currently undergoing treatment or have been diagnosed recently.
  • Individuals who have had a **major surgery** within the last 3 months cannot participate. Major surgery is a significant operation that requires a long recovery time.
  • People with **uncontrolled diabetes** are not eligible. This means if your blood sugar levels are not stable or well-managed, you cannot join.
  • Pregnant or breastfeeding women are excluded from the study.
  • Anyone with a known allergy to the study medication or its ingredients cannot participate.
  • Participants who are currently enrolled in another clinical trial are not eligible.
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Investigated drugs

Roxadustat is a medication being studied for its potential effects on heart health and metabolism. It is being tested to see how it might help manage blood sugar levels and fat in the body, as well as improve heart function. This medication works by encouraging the body to produce more red blood cells, which can improve oxygen delivery throughout the body. Researchers are interested in understanding how these effects might benefit people with certain health conditions, particularly those related to the heart and metabolism.

What is already known about the treatment

Roxadustat – Roxadustat is administered orally in the form of a tablet. It is currently being studied in clinical trials to understand its effects on glucose and lipid metabolism, as well as cardiovascular function. The main therapeutic indications for Roxadustat include addressing risk factors of cardiovascular disease and metabolic syndrome. At the molecular level, Roxadustat works by stimulating the production of red blood cells, which can improve oxygen delivery in the body and potentially influence metabolic processes. It is classified pharmacologically as a hypoxia-inducible factor prolyl hydroxylase inhibitor.

Investigated diseases

  • Cardiovascular Disease Risk Factors

    Cardiovascular disease risk factors are conditions or behaviors that increase the likelihood of developing heart-related problems. These include high blood pressure, high cholesterol levels, smoking, obesity, physical inactivity, and unhealthy diet. Over time, these factors can lead to the buildup of plaque in the arteries, known as atherosclerosis, which can restrict blood flow. This process can progress silently, often without symptoms, until it results in serious events like heart attacks or strokes. Managing these risk factors is crucial to maintaining heart health and preventing disease progression.

  • Metabolic Syndrome

    Metabolic syndrome is a cluster of conditions that occur together, increasing the risk of heart disease, stroke, and type 2 diabetes. These conditions include increased blood pressure, high blood sugar levels, excess body fat around the waist, and abnormal cholesterol or triglyceride levels. The syndrome is characterized by insulin resistance, where the body's cells do not respond effectively to insulin. Over time, this can lead to increased blood sugar levels and further complications. The progression of metabolic syndrome can be gradual, often developing over several years, and is influenced by lifestyle factors such as diet and physical activity.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508183-29-00Estimated enrolment24 patientsSponsorPohjois-Pohjanmaan hyvinvointialue

sourced from the EU Clinical Trials Register and site verification

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