Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Effects of Finerenone for Patients with Type 2 Diabetes and Early Diabetic Cardiovascular Autonomic Neuropathy

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The FibroCAN study is focused on understanding the effects of a medication called Finerenone on a condition known as diabetic cardiovascular autonomic neuropathy, which affects people with type 2 diabetes. This condition involves damage to the nerves that control the heart and blood vessels, leading to issues with heart function. The study will explore how Finerenone, a type of medication known as a mineralocorticoid receptor antagonist, might help modify the disease in its early stages.

The purpose of the study is to investigate the potential benefits of Finerenone in improving nerve function, reducing fibrosis (a process where tissues become thickened and scarred), and decreasing inflammation in the body. Participants will be randomly assigned to receive either Finerenone or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This approach is known as a double-blind study, which helps ensure the results are unbiased.

The study will last for 78 weeks, during which participants will undergo various tests to assess nerve function, heart health, and levels of fibrosis and inflammation. These tests will help researchers understand how Finerenone affects the body and whether it can provide benefits for people with early-stage diabetic cardiovascular autonomic neuropathy. The findings from this study could lead to better treatment options for managing this condition in the future.

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

    Joining the study

    Upon joining the study, the participant is required to provide informed consent, confirming understanding and agreement to participate.

    Eligibility is confirmed based on criteria such as having type 2 diabetes, being 40 years or older, and having a specific E/I ratio.

  2. Step 2

    Randomization and blinding

    Participants are randomly assigned to receive either the finerenone treatment or a placebo. This process is double-blinded, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Treatment administration

    The treatment involves taking finerenone in the form of a film-coated tablet. The medication is taken orally.

    The duration of the treatment is 78 weeks, during which the participant will follow the prescribed dosage and frequency as instructed by the study protocol.

  4. Step 4

    Monitoring and assessments

    Throughout the study, various assessments are conducted to monitor the effects of the treatment. These include cardiovascular reflex tests and heart rate variability indices.

    Markers of fibrosis and inflammation are measured through blood tests and skin biopsies at specific intervals, such as weeks 0, 36, and 78.

  5. Step 5

    Completion of the study

    At the end of the 78-week period, the participant completes the study. Final assessments are conducted to evaluate the outcomes of the treatment.

Who can join the trial?

4 criteria

  • Must have given informed consent, which means you understand the study and agree to participate.
  • Must have Type 2 diabetes, a condition where the body doesn't use insulin properly, as defined by the World Health Organization (WHO).
  • Must be aged 40 or older at the time of joining the study.
  • Must have a pathological E/I ratio, which is a specific measure related to heart function. This involves taking the average of three measurements.

Who cannot join the trial?

4 criteria

  • Patients who do not have **type 2 diabetes** cannot participate. **Type 2 diabetes** is a condition where the body does not use insulin properly, leading to high blood sugar levels.
  • Patients who do not have **early-stage CAN** cannot participate. **CAN** stands for **cardiovascular autonomic neuropathy**, which is a type of nerve damage that affects the heart and blood vessels.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Finerenone is a medication being studied for its potential to modify the progression of diabetic cardiovascular autonomic neuropathy (CAN) in people with type 2 diabetes. This trial aims to explore how finerenone affects nerve damage, fibrosis, inflammation, and heart function over a period of 78 weeks. Finerenone is a type of mineralocorticoid receptor antagonist, which means it works by blocking certain receptors in the body that can contribute to heart and kidney problems.

What is already known about the treatment

Finerenone – Finerenone is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating diabetic cardiovascular autonomic neuropathy, a condition affecting the nerves that control the heart and blood vessels in people with diabetes. The medication works by blocking mineralocorticoid receptors, which are involved in the regulation of blood pressure and inflammation. This action may help reduce fibrosis and inflammation, potentially improving heart function. Finerenone is classified as a mineralocorticoid receptor antagonist.

Investigated diseases

Diabetic Cardiovascular Autonomic Neuropathy – This condition is a complication of diabetes that affects the autonomic nerves controlling the heart and blood vessels. It can lead to abnormalities in heart rate and blood pressure regulation. As the disease progresses, individuals may experience symptoms such as dizziness, fainting, or exercise intolerance due to impaired cardiovascular responses. Over time, the condition can result in a reduced ability to regulate heart rate and blood pressure during physical activities or stress. It is often associated with other diabetic complications and can significantly impact the quality of life. The progression of this neuropathy is typically gradual and may vary among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516597-30-00Estimated enrolment100 patientsSponsorSteno Diabetes Center Copenhagen

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).