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Study of PF-07328948 tablets compared to placebo in adults with heart failure to evaluate effects on symptoms and physical function

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What is this trial about?

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

This study focuses on people with Heart Failure, a condition where the heart cannot pump blood effectively throughout the body. The study will test a new medication called PF-07328948, which is taken as tablets by mouth. Some participants will receive the actual medication while others will receive a placebo. The purpose is to evaluate how well this new drug works and how safe it is for adults with heart failure when taken daily for 36 weeks.

The study will look at patients who have a specific type of heart failure where the heart's ability to pump blood is only mildly reduced or preserved. Participants must have certain signs of heart failure, including elevated pressure in the heart chambers or previous hospital visits for heart failure symptoms. The study will measure how the treatment affects important aspects of the condition, such as physical function and quality of life.

Throughout the study, researchers will track any heart-related events, measure how far participants can walk in 6 minutes, and assess how participants feel in their daily activities. They will also monitor the levels of substances in the blood that indicate heart stress and keep track of any side effects that may occur during treatment. All participants must also be taking another type of medication called an SGLT2 inhibitor before and during the study.

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 screening visit

    During the first visit, your basic health parameters will be checked, including blood tests, body mass index (BMI), and heart function tests

    A special test called 6-minute walk test will be performed to measure your physical ability

    You will complete a questionnaire about your heart failure symptoms

  2. Step 2

    Heart examination

    An echocardiogram (heart ultrasound) will be performed to check your heart function

    The test will measure your heart's pumping ability and structure

  3. Step 3

    Medication assignment

    You will be randomly assigned to receive either PF-07328948 tablets or placebo tablets

    The medication or placebo will be taken orally each day

    You must continue taking your current heart medication, including SGLT2 inhibitor (a type of diabetes medication that also helps with heart failure)

  4. Step 4

    Treatment period

    The treatment will continue for 36 weeks

    Regular check-ups will be scheduled to monitor your health

    Your heart function, physical ability, and quality of life will be assessed throughout the study

  5. Step 5

    Final assessment

    At week 36, final tests will be performed, including:

    Another 6-minute walk test to measure changes in physical ability

    Blood tests to check heart failure markers

    Quality of life questionnaire completion

    For some participants: a special exercise test to measure oxygen use during activity

Who can join the trial?

17 criteria

  • Must be aged 18 years or older (up to 80 years in EU)
  • Must have been diagnosed with chronic heart failure for at least 3 months
  • Must have a Body Mass Index (BMI) of 27.0 to 50.0, or lower BMI if you have type 2 diabetes, are using specific medications, or have increased waist circumference (over 37 inches for men or 31 inches for women)
  • Must be receiving SGLT2i therapy (a type of diabetes medication) for at least 30 days before starting the study
  • Must have specific heart measurements showing:
    • Heart pumping function (ejection fraction) above 40%
    • Certain structural heart changes if ejection fraction is 50% or higher
    • Must have at least one of these conditions:
      • Elevated levels of specific heart proteins in blood tests
      • Evidence of increased heart pressure in previous tests
      • Recent hospital stay for heart failure treatment
      • Recent urgent care visit for heart failure treatment
      • Must be able to walk at least 75 meters in a 6-minute walking test
      • Must have specific blood sugar levels (HbA1c) between 5.7% and 10.0%
      • Women who can become pregnant must:
        • Have a negative pregnancy test
        • Agree to use effective birth control
        • Not be breastfeeding
        • Must sign an informed consent form
        • Must be willing to attend all study visits and complete all required procedures

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions to medications or multiple drug allergies
  • Current pregnancy or breastfeeding
  • Severe kidney disease requiring dialysis (a medical procedure to filter blood when kidneys don't work properly)
  • Severe liver disease (conditions that significantly affect liver function)
  • Recent heart attack or stroke (within the last 3 months)
  • Active or recent cancer treatment within the past year
  • Participation in other clinical trials within the last 30 days
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • History of substance abuse within the past year
  • Mental health conditions that could interfere with study participation
  • Unable to provide informed consent (understanding and agreeing to participate in the study)
  • Blood disorders that increase risk of bleeding
  • Life expectancy less than 12 months due to other medical conditions
  • Unable to take medications by mouth
  • History of not following medical treatment plans
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Investigated drugs

PF-07328948 is an oral branched-chain ketoacid dehydrogenase kinase inhibitor being studied for the treatment of heart failure. This medication is designed to help patients who have heart failure with mildly reduced or preserved ejection fraction (types of heart failure where the heart's ability to pump blood is affected). The medication is taken by mouth and aims to improve physical function and symptoms in people with heart failure while potentially reducing cardiovascular-related events.

What is already known about the treatment

PF-07328948 - An oral branched-chain ketoacid dehydrogenase kinase inhibitor that is currently being investigated in Phase 2 clinical trials for the treatment of heart failure, specifically in patients with heart failure with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF). The medication is administered orally on a daily basis and works by inhibiting the branched-chain ketoacid dehydrogenase kinase, which plays a role in cardiac metabolism. This investigational drug is being studied to evaluate its efficacy in reducing cardiovascular death and worsening heart failure events, as well as improving physical function and symptoms in heart failure patients.

Investigated diseases

Heart Failure - A chronic condition where the heart cannot pump blood effectively enough to meet the body's needs. The heart muscle becomes weaker over time or has difficulty filling with blood. This leads to symptoms such as shortness of breath, fatigue, and fluid retention in various parts of the body, particularly the legs and lungs. Heart failure can develop gradually as the heart tries to compensate for its weakening function by enlarging, developing more muscle mass, or pumping faster. The condition can affect either the left side, right side, or both sides of the heart.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518438-94-00Protocol codeC4921003Estimated enrolment620 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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