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Study of LY3540378 for Adults with Worsening Chronic Heart Failure with Preserved Ejection Fraction

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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 a condition known as Heart Failure with Preserved Ejection Fraction (HFpEF), which is a type of heart failure where the heart muscle contracts normally but the ventricles do not relax as they should during heartbeats. The study is investigating a treatment called LY3540378, which is a solution for injection. This treatment involves a special protein that is designed to help improve heart function in people with worsening chronic HFpEF.

The purpose of the study is to determine if LY3540378 is more effective than a placebo in improving a condition called atrial myopathy, which affects the upper chambers of the heart. Participants in the study will receive either the treatment or a placebo, and the effects on their heart condition will be monitored over time. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will undergo various assessments to track changes in their heart health, particularly focusing on a measure called Left Atrial Reservoir Strain (LARS), which helps evaluate how well the heart is functioning. The study aims to provide valuable insights into the potential benefits of LY3540378 for individuals with HFpEF, contributing to better treatment options for this challenging 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

    Enrollment and initial assessment

    Upon joining the study, participants will undergo an initial assessment to confirm eligibility. This includes a review of medical history and current health status to ensure the presence of chronic heart failure with preserved ejection fraction (HFpEF).

  2. Step 2

    Randomization

    Participants will be randomly assigned to receive either the investigational medication LY3540378 or a placebo. This process is double-blind, meaning neither the participants nor the researchers will know which treatment is being administered.

  3. Step 3

    Treatment administration

    The assigned treatment, either LY3540378 or placebo, will be administered as a solution for injection through the skin (cutaneous use). The specific dosage, frequency, and duration of administration will be provided by the study team.

  4. Step 4

    Monitoring and follow-up

    Participants will be regularly monitored throughout the study to assess the treatment's effects on heart function. This includes measuring changes in the left atrial reservoir strain (LARS), which is an indicator of heart health.

  5. Step 5

    Completion and final assessment

    At the end of the study period, participants will undergo a final assessment to evaluate the overall impact of the treatment on their heart condition. This will help determine the efficacy and safety of LY3540378 compared to the placebo.

Who can join the trial?

4 criteria

  • Must have chronic heart failure. This means the heart does not pump blood as well as it should over a long period.
  • Must have Heart Failure with Preserved Ejection Fraction (HFpEF). This is a type of heart failure where the heart pumps normally but is too stiff to fill properly.
  • Open to both men and women.
  • Participants should be adults, typically aged 18 and older.

Who cannot join the trial?

10 criteria

  • Patients with any other serious medical condition that might interfere with the study.
  • Patients who have had a recent heart attack or stroke.
  • Patients with severe kidney disease.
  • Patients with severe liver disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication.
  • Patients who have a mental health condition that might interfere with their ability to participate in the study.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

LY3540378 is a medication being tested in this clinical trial to see if it can help people with a type of heart failure called chronic heart failure with preserved ejection fraction (HFpEF). This condition means that the heart has trouble relaxing and filling with blood properly, even though it can still pump blood out to the body. The trial is looking at whether LY3540378 can improve a specific heart problem called atrial myopathy, which affects the upper chambers of the heart. The medication is given as an injection under the skin, and researchers are comparing it to a placebo to see if it works better in helping the heart function more effectively.

What is already known about the treatment

LY3540378 – LY3540378 is administered through a subcutaneous injection, which means it is given under the skin. It is currently being studied in clinical trials to assess its effectiveness and safety for treating heart failure, specifically heart failure with preserved ejection fraction (HFpEF). The main goal of this medication is to improve heart function in people whose heart failure symptoms are getting worse. At the molecular level, LY3540378 works by targeting specific pathways in the heart to reduce stress and improve heart muscle function. It is classified as a cardiovascular agent, which means it is designed to help with heart-related conditions.

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 fatigue, shortness of breath, and fluid retention. The heart's ability to pump blood diminishes over time, leading to a reduced capacity for physical activity. This condition can affect either the left, right, or both sides of the heart. It often requires lifestyle adjustments to manage symptoms and improve quality of life.

  • Heart Failure with Preserved Ejection Fraction

    Heart failure with preserved ejection fraction (HFpEF) is a type of heart failure where the heart's pumping ability is normal, but the heart muscle is stiff and does not relax properly. This stiffness leads to increased pressure in the heart and lungs, causing symptoms like shortness of breath and fatigue. Over time, the heart's ability to fill with blood during the resting phase is impaired, leading to congestion and fluid buildup. HFpEF is often associated with conditions such as hypertension and diabetes. The disease progresses as the heart's filling capacity continues to decline. It requires careful management to alleviate symptoms and maintain heart function.

Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IITrial ID2023-505902-40-00Protocol codeJ3E-MC-EZDBEstimated enrolment460 patientsSponsorEli Lilly & Co.

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