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Study of XXB750 and Drug Combination for Patients with Heart Failure

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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 Heart Failure, a condition where the heart doesn't pump blood as well as it should. The study will evaluate a new treatment called XXB750, which is being tested to see how effective and safe it is for patients with heart failure. The trial will compare different doses of XXB750 to a placebo to understand its impact on heart failure symptoms and a specific heart-related protein called NT-proBNP, which is often elevated in heart failure patients.

Participants in the study will receive either XXB750 or a placebo over a period of 16 weeks. The study aims to find the best dose of XXB750 that can help reduce the levels of NT-proBNP, which is a marker used to assess heart failure severity. Patients will continue to receive their standard heart failure treatments, such as ACE inhibitors or ARBs, which are common medications used to manage heart failure symptoms.

The trial will monitor changes in NT-proBNP levels and assess any side effects or changes in health during the study period. This research is important to determine if XXB750 can be a beneficial addition to existing heart failure treatments, potentially improving the quality of life for those affected by this condition.

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, informed consent is required. This means agreeing to participate after understanding the study's purpose and procedures.

    Eligibility is confirmed based on specific criteria, such as age, heart failure symptoms, and current treatments.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline data. This includes measuring heart function and levels of a specific heart-related protein in the blood.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to receive either the study medication XXB750 or a placebo. The medication is administered as a solution for injection.

    The study medication is given at different dose levels to evaluate its effects. The treatment lasts for 24 weeks.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring occurs throughout the study to assess the medication's effects and any side effects. This includes blood tests and heart function evaluations.

    Participants continue their standard heart failure treatments alongside the study medication.

  5. Step 5

    Final assessment

    At the end of the 24-week period, a final assessment is conducted. This includes measuring changes in heart-related protein levels and overall health status.

Who can join the trial?

7 criteria

  • You must provide written informed consent before any study-related assessments are done. This means you agree to participate after understanding the study details.
  • You must be an outpatient, meaning you are not currently admitted to a hospital, and be at least 18 years old.
  • You should have symptoms of Heart Failure (HF) classified as NYHA class II-III. This refers to a specific level of heart failure symptoms.
  • Your Left Ventricular Ejection Fraction (LVEF) must be less than 50%. LVEF is a measure of how well your heart pumps blood. This should be based on a recent test done within the last 6 months.
  • Your NT-proBNP level should be at least 600 pg/ml if your heart rhythm is normal (sinus rhythm) or at least 900 pg/ml if you have atrial fibrillation/flutter. NT-proBNP is a blood test that helps assess heart failure.
  • You must be taking an ACEI (Angiotensin-Converting Enzyme Inhibitor) or an ARB (Angiotensin Receptor Blocker) at a stable dose for at least 4 weeks before the screening. Alternatively, you can be taking sacubitril/valsartan at a stable dose for the same period.
  • You should be on other recommended heart failure treatments as appropriate, and these treatments should be stable for at least 4 weeks before the screening. This is unless these treatments are not suitable for you, you cannot tolerate them, or they are not available to you.

Who cannot join the trial?

9 criteria

  • Patients with a history of severe allergic reactions to any of the study medications.
  • Individuals with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication.
  • Patients who have had a heart attack or stroke within the last 3 months.
  • People with severe kidney disease, which affects how well the kidneys work.
  • Individuals with liver disease that is not stable or well-controlled.
  • Patients who are currently participating in another clinical trial.
  • Women who are pregnant or breastfeeding.
  • Individuals with a history of drug or alcohol abuse within the past year.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • XXB750

    is an investigational medication being studied for its potential to help patients with heart failure. The trial aims to determine how effective XXB750 is at reducing a specific heart failure marker in the blood, known as NT-proBNP, over a period of 16 weeks. This medication is being tested in different dose levels to find the most effective dose for patients with heart failure who have a reduced ejection fraction.

  • ACE Inhibitors (ACEI)

    are medications commonly used to treat heart failure. They work by relaxing blood vessels, which lowers blood pressure and makes it easier for the heart to pump blood. In this trial, patients may be receiving ACE inhibitors as part of their standard care.

  • Angiotensin Receptor Blockers (ARB)

    are another type of medication used in heart failure treatment. They help relax blood vessels and lower blood pressure, similar to ACE inhibitors, but work through a slightly different mechanism. Patients in the trial may be using ARBs as part of their regular treatment.

  • Sacubitril/Valsartan

    is a combination medication used to treat heart failure. It combines two different types of drugs: sacubitril, which helps the heart work better by increasing certain beneficial substances in the body, and valsartan, which lowers blood pressure by relaxing blood vessels. This combination is part of the standard care for some patients in the trial.

What is already known about the treatment

XXB750 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating heart failure. It is in the investigational stage, with ongoing research to determine its efficacy and safety. The main therapeutic indication for XXB750 is heart failure, particularly in patients with a reduced ejection fraction. At the molecular level, XXB750 is believed to work by influencing pathways that reduce levels of N-terminal prohormone B-type natriuretic peptide (NT-proBNP), a marker associated with heart failure severity. It is classified pharmacologically as a heart failure treatment agent.

Investigated diseases

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It can result from various underlying heart conditions that weaken or damage the heart muscle. As the disease progresses, individuals may experience symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. The heart's reduced ability to pump blood can lead to fluid buildup in the lungs and other parts of the body. Over time, the heart may become enlarged as it works harder to pump blood. This condition requires ongoing management to help alleviate symptoms and improve quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504678-39-00Protocol codeCXXB750A12201Estimated enrolment740 patientsSponsorNovartis Pharma AG

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