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Bi 690517

BI 690517, also known as Vicadrostat, is an investigational drug currently being studied in various clinical trials. These trials aim to evaluate its safety, efficacy, and potential benefits in treating chronic kidney disease, particularly in patients with diabetic nephropathy. The studies explore how the drug is absorbed and processed by the body, its effects on kidney function, and its potential to slow the progression of kidney disease when used alone or in combination with other medications.

Table of Contents

What is BI 690517?

BI 690517, also known as Vicadrostat, is a new drug being developed by pharmaceutical researchers[1]. It is currently undergoing clinical trials to evaluate its effectiveness and safety in treating various conditions, primarily related to kidney and heart diseases[4][5]. The drug is taken orally, usually in the form of tablets[6].

What Conditions Does BI 690517 Treat?

Based on the ongoing clinical trials, BI 690517 is being studied for its potential to treat:

  • Chronic Kidney Disease (CKD): This is a condition where the kidneys are damaged and cannot filter blood as well as they should. BI 690517 is being tested to see if it can slow down the progression of CKD and reduce related complications[4].
  • Heart Failure: This is a condition where the heart cannot pump blood effectively to meet the body’s needs. BI 690517 is being studied to determine if it can help improve symptoms and outcomes in patients with heart failure[5].

How Does BI 690517 Work?

BI 690517 is classified as an aldosterone synthase inhibitor[4]. To understand how it works:

  • Aldosterone is a hormone that helps regulate blood pressure and the balance of salt and water in the body.
  • Aldosterone synthase is an enzyme that produces aldosterone.
  • By inhibiting (blocking) aldosterone synthase, BI 690517 aims to reduce the production of aldosterone in the body.

Excessive aldosterone can contribute to high blood pressure, fluid retention, and damage to the heart and kidneys. By reducing aldosterone levels, BI 690517 may help protect these organs and improve overall health in patients with kidney and heart diseases[4][5].

Clinical Trials and Research

BI 690517 is currently being studied in several clinical trials to evaluate its effectiveness, safety, and how it’s processed by the body (pharmacokinetics). Some key aspects of these trials include:

  • Dose-finding studies: Researchers are testing different doses of BI 690517 to determine the most effective and safe dose for patients[8][9].
  • Effects on kidney function: Studies are measuring how BI 690517 affects markers of kidney health, such as the urine albumin-to-creatinine ratio (UACR), which indicates the amount of protein in the urine[6].
  • Heart failure outcomes: Researchers are investigating whether BI 690517 can reduce hospitalizations for heart failure and improve survival in patients with heart problems[5].
  • Long-term effects: Some trials are designed to last several years to assess the long-term benefits and safety of BI 690517[4].

Combination Therapy with Empagliflozin

Many of the clinical trials are studying BI 690517 in combination with another drug called empagliflozin[4][5][6]. Empagliflozin is a medication already approved for treating type 2 diabetes and heart failure. The combination of these two drugs may provide additional benefits for patients with kidney and heart diseases. Researchers are investigating whether this combination can:

  • Slow down the progression of chronic kidney disease more effectively than either drug alone.
  • Reduce the risk of hospitalization and death in patients with heart failure.
  • Improve overall kidney and heart health outcomes.

Safety and Side Effects

As BI 690517 is still in the research phase, its full safety profile and potential side effects are not yet fully known. The ongoing clinical trials are carefully monitoring participants for any adverse events (unwanted side effects)[1][8]. Some studies are specifically designed to assess how well the drug is tolerated by different groups of people, including:

  • Healthy volunteers[1][7]
  • Patients with liver problems[2]
  • People of different ethnicities, such as Chinese and Japanese participants[10][9]

These safety studies help researchers understand how the drug affects different populations and identify any potential risks or side effects.

Future Prospects

While BI 690517 shows promise in early research, it’s important to note that it is still an experimental drug. The results of the ongoing clinical trials will determine whether it becomes approved for use in patients. If successful, BI 690517 could potentially offer a new treatment option for people with chronic kidney disease and heart failure, especially those who may not respond well to existing therapies[4][5].

As research continues, more information will become available about the effectiveness, safety, and potential uses of BI 690517. Patients interested in this drug should discuss with their healthcare providers about the latest developments and whether participating in a clinical trial might be appropriate for their individual situation.

Aspect Details
Drug Name BI 690517 (Vicadrostat)
Primary Focus Treatment of chronic kidney disease, particularly diabetic nephropathy
Trial Types Phase I, II, and III studies
Study Populations Healthy volunteers, patients with chronic kidney disease, diabetic nephropathy patients
Key Outcomes Measured Safety, tolerability, pharmacokinetics, pharmacodynamics, kidney function markers (e.g., UACR, eGFR)
Administration Oral tablets, various dosing regimens
Combination Therapies Studied with empagliflozin, ACEi, ARBs
Special Populations Studies in Chinese and Japanese participants, patients with liver impairment
Potential Benefits May slow kidney disease progression, reduce risk of heart failure and cardiovascular events

FAQ

  • What is BI 690517 (Vicadrostat)? BI 690517, also known as Vicadrostat, is an investigational drug being studied for its potential to treat chronic kidney disease, particularly in patients with diabetic nephropathy. It is believed to work by inhibiting aldosterone synthase, which may help protect the kidneys.
  • What are the main goals of the clinical trials involving BI 690517? The main goals of these trials are to assess the safety and tolerability of BI 690517, understand how it is absorbed and processed by the body (pharmacokinetics), evaluate its effects on kidney function, and determine its potential to slow the progression of kidney disease.
  • Who can participate in these clinical trials? Different trials have different eligibility criteria. Some studies involve healthy volunteers, while others focus on patients with chronic kidney disease or diabetic nephropathy. Some trials specifically recruit Chinese and Japanese participants to study ethnic differences in drug response.
  • How is BI 690517 administered in these trials? BI 690517 is typically administered orally as a tablet. The dosage and frequency vary depending on the specific trial, with some studies testing single doses and others exploring multiple doses over several days or weeks.
  • What are some of the outcomes being measured in these trials? Key outcomes being measured include safety indicators such as adverse events, changes in kidney function markers like urine albumin-to-creatinine ratio (UACR), and pharmacokinetic parameters such as the drug's concentration in the blood over time. Some trials also look at the drug's effects on heart failure and cardiovascular health.

Ongoing Clinical Trials on Bi 690517

  • Study of vicadrostat and empagliflozin combination in patients with type 2 diabetes, high blood pressure and cardiovascular disease

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +17

  • A study to compare the effects of BI 690517 and spironolactone on kidney function in patients with heart failure, cardiovascular disease, or chronic kidney disease

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Evaluating the Effect of Vicadrostat and Empagliflozin Combination Compared to Empagliflozin Alone in Patients with Heart Failure and Reduced Left Ventricular Function

    Recruiting

    3 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark Germany Hungary +6

  • Study on BI 690517 and Empagliflozin for Patients with Heart Failure and Preserved Ejection Fraction

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Germany Hungary Italy +5

  • Study of vicadrostat and empagliflozin given together or separately in people with chronic kidney disease to test safety and effectiveness

    Not recruiting

    2 1 1
    Investigated drugs:
    Belgium Czechia France Germany Italy The Netherlands +2

Glossary

  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body over time.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body, including their mechanisms of action and the relationship between drug concentration and effect.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • Urine Albumin-to-Creatinine Ratio (UACR): A test that measures the amount of albumin in urine compared to creatinine, used to detect early signs of kidney damage.
  • Diabetic Nephropathy: Kidney damage that occurs as a complication of diabetes, often leading to chronic kidney disease.
  • Aldosterone Synthase: An enzyme involved in the production of aldosterone, a hormone that regulates blood pressure and fluid balance in the body.
  • Glomerular Filtration Rate (eGFR): A measure of how well the kidneys are filtering waste from the blood, estimated using a blood test.
  • Angiotensin Converting Enzyme inhibitor (ACEi): A type of medication used to treat high blood pressure and heart failure, which can also help protect the kidneys in people with diabetes.
  • Angiotensin Receptor Blocker (ARB): Another type of medication used to treat high blood pressure and heart problems, which may also provide kidney protection.
  • Placebo: An inactive substance or treatment used in clinical trials as a control to compare with the effects of the drug being tested.

References

  1. https://clinicaltrials.gov/study/NCT05515588
  2. https://clinicaltrials.gov/study/NCT05731908
  3. https://clinicaltrials.gov/study/NCT06647810
  4. https://clinicaltrials.gov/study/NCT06531824
  5. https://clinicaltrials.gov/study/NCT06424288
  6. https://clinicaltrials.gov/study/NCT05182840
  7. https://clinicaltrials.gov/study/NCT02891148
  8. https://clinicaltrials.gov/study/NCT03100916
  9. https://clinicaltrials.gov/study/NCT03608072
  10. https://clinicaltrials.gov/study/NCT03206632