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Study of maridebart cafraglutide for patients with heart failure with preserved or mildly reduced ejection fraction and obesity

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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 studying a new treatment for people who have Heart Failure with Preserved or Mildly Reduced Ejection Fraction and are also living with obesity. The study will test a medication called maridebart cafraglutide (also known as AMG 133), which is given as an injection under the skin. Some participants will receive the study medication while others will receive placebo. The purpose of this research is to determine if the medication can reduce heart failure-related hospital visits and deaths in people with this specific type of heart condition who also have a high body weight.

The treatment involves regular injections of either maridebart cafraglutide or placebo, given in addition to standard heart failure treatments that participants are already receiving. The study will monitor how the medication affects participants' heart health, particularly focusing on heart failure events that require medical attention and heart-related deaths.

During the study, researchers will track various aspects of participants' health, including their heart function and quality of life. They will use questionnaires to assess how participants are feeling and functioning in their daily activities. The study will also monitor other important heart-related events such as myocardial infarction (heart attack) and ischemic stroke.

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 evaluation

    Your heart function will be evaluated to confirm that you have heart failure with preserved or mildly reduced ejection fraction (a condition where your heart pumps normally but doesn't fill properly with blood).

    Your body mass index (BMI) will be measured to confirm it is 30 or higher.

    A blood test will check your NT-proBNP levels (a substance that indicates heart stress).

  2. Step 2

    Medical imaging

    An echocardiogram (heart ultrasound) will be performed to examine your heart structure.

    The test will measure various aspects of your heart, including chamber sizes and wall thickness.

  3. Step 3

    Treatment assignment

    You will be randomly assigned to receive either maridebart cafraglutide (AMG 133) or a placebo.

    The medication or placebo will be given as an injection under the skin (subcutaneous injection).

    This is a double-blind study, which means neither you nor your doctor will know which treatment you are receiving.

  4. Step 4

    Treatment period

    You will receive regular injections of either the study medication or placebo.

    The treatment period will continue until the study ends in September 2030.

    Your heart health will be monitored throughout the study period.

    You will complete questionnaires about your symptoms and quality of life at various points during the study, including at week 48.

  5. Step 5

    Monitoring

    Regular check-ups will track your heart health and any heart-related events.

    The study will monitor for events such as hospitalization for heart failure, urgent heart failure visits, or heart-related health issues.

    Your overall health and any changes in your condition will be regularly assessed.

Who can join the trial?

8 criteria

  • Must be at least 18 years old or older if required by local law
  • Must have a Body Mass Index (BMI) of 30 or higher at screening (BMI is a measure of body fat based on height and weight)
  • Must have been diagnosed with heart failure for at least 30 days before screening with New York Heart Association (NYHA) Class II-IV symptoms at screening (symptoms ranging from mild to severe limitations in physical activity)
  • Must be on stable heart failure medications for at least 14 days before screening
  • Must have a left ventricular ejection fraction greater than 40% measured within the last 12 months (this measures how well your heart pumps blood)

  • Must have elevated NT-proBNP levels (a blood test that helps diagnose heart failure):

    • Above 300 pg/mL for patients with normal heart rhythm
    • Above 600 pg/mL for patients with atrial fibrillation or flutter

  • Must have at least one of these conditions:

    • Specific heart structure changes shown on an echocardiogram
    • Hospital stay for heart failure requiring IV medication in the past 12 months
    • Evidence of high heart filling pressures in the past 12 months
  • For participants with Type 2 diabetes: Must be on stable diabetes treatment (diet, exercise, or medications) for at least 30 days before starting the study

Who cannot join the trial?

14 criteria

  • Age below 18 years old
  • Current pregnancy or breastfeeding
  • Body Mass Index (BMI) less than 30 kg/m² (a measurement that uses height and weight to determine if someone is overweight)
  • Ejection fraction (the percentage of blood pumped out of the heart with each beat) outside the preserved or mildly reduced range
  • Severe heart failure symptoms that require immediate hospitalization
  • History of severe allergic reactions to similar medications
  • Participation in other clinical trials within the past 30 days
  • Unstable heart condition requiring urgent medical intervention
  • Severe kidney or liver disease
  • Inability to provide informed consent
  • History of drug or alcohol abuse within the past year
  • Life-threatening illness other than heart failure
  • Use of medications that could interact with the study drug
  • Mental conditions that could interfere with study participation
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Investigated drugs

  • Maridebart cafraglutide

    is a new investigational medication being studied for treating heart failure in people who also have obesity. It is designed to help patients who have a specific type of heart failure where their heart can still pump blood relatively well (preserved or mildly reduced ejection fraction). The medication is being tested as an additional treatment alongside standard heart failure medications to see if it can reduce hospitalizations due to heart failure and improve survival rates.

  • Placebo

    is an inactive substance that looks identical to the study medication but contains no active ingredients. It is used to compare the effects of the active medication and determine if maridebart cafraglutide provides real benefits to patients.

What is already known about the treatment

Maridebart cafraglutide - A novel investigational medication being studied in Phase 3 clinical trials for the treatment of heart failure in patients with preserved or mildly reduced ejection fraction who also have obesity (BMI ≥ 30). The drug is being evaluated as an addition to standard heart failure treatments, with the primary goal of reducing hospitalizations, urgent heart failure visits, and cardiovascular-related deaths. While the exact mechanism of action is still under investigation in clinical trials, it belongs to the class of medications known as GLP-1 receptor agonists, which are commonly used in treating conditions related to metabolism and cardiovascular health. The medication represents a potential new therapeutic approach combining management of both heart failure and obesity in a single treatment option.

Investigated diseases

  • Heart Failure with Preserved Ejection Fraction

    A type of heart failure where the heart muscle contracts normally but doesn't relax properly between beats, reducing the heart's ability to fill with blood. This condition leads to less blood being pumped throughout the body, causing symptoms like shortness of breath and fatigue. The heart maintains a normal ejection fraction of 50% or higher, despite the heart's compromised filling ability.

  • Heart Failure with Mildly Reduced Ejection Fraction

    A form of heart failure where the heart's pumping function is slightly decreased, with ejection fraction typically ranging between 40% and 49%. The heart muscle becomes mildly weakened but can still pump a significant portion of blood with each contraction. This condition can cause similar symptoms to other types of heart failure, including reduced exercise tolerance and fluid retention.

  • Obesity

    A chronic condition characterized by excessive accumulation of body fat, typically measured by a Body Mass Index (BMI) of 30 or higher. The condition develops gradually as a result of consuming more calories than the body uses over an extended period. It affects multiple body systems and can impact overall physical functioning. The excess weight puts additional strain on the body's organs and skeletal system.

Trial detailsLast updated 24 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516654-22-00Protocol code20230227Estimated enrolment5 056 patientsSponsorAmgen Inc.

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