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Study on JTT-861 for Patients with Heart Failure with Reduced 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 Reduced Ejection Fraction (HFrEF). This is a type of heart failure where the heart muscle does not contract effectively, and less oxygen-rich blood is pumped out to the body. The study will evaluate a new treatment called JTT-861, which is taken as a capsule. The purpose of the study is to assess how well JTT-861 works, its safety, and how the body processes it over a period of 12 weeks.

Participants in the study will be randomly assigned to receive either the JTT-861 capsule or a placebo tablet. 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. This helps ensure that the results are not biased. The study will last for 12 weeks, during which participants will take the assigned capsule daily. Throughout the study, participants will have regular check-ups to monitor their heart function and overall health.

The study aims to gather information on how JTT-861 affects heart function, including changes in heart size and pumping ability, as well as levels of certain proteins in the blood that are related to heart failure. Safety will also be closely monitored by checking for any side effects and changes in vital signs. This research is important for understanding whether JTT-861 could be a beneficial treatment option for people with heart failure.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as age, heart failure diagnosis, and current treatment regimen.

    Participants must have a left ventricular ejection fraction of 35% or less and specific levels of a heart-related protein in the blood.

  2. Step 2

    Randomization and treatment assignment

    Participants are randomly assigned to receive either the study medication, JTT-861, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives which treatment.

  3. Step 3

    Medication administration

    The study medication, JTT-861, is administered orally in capsule form.

    Participants take the medication daily for a duration of 12 weeks.

  4. Step 4

    Monitoring and assessments

    Throughout the 12-week period, participants undergo regular assessments to monitor heart function and overall health.

    These assessments include echocardiograms to evaluate heart structure and function, as well as blood tests to measure specific proteins and other health indicators.

  5. Step 5

    Pharmacokinetic evaluations

    Blood samples are collected at weeks 2, 4, 8, and 12 to measure the concentration of JTT-861 in the bloodstream.

    These evaluations help understand how the body processes the medication.

  6. Step 6

    Completion of treatment

    At the end of the 12-week treatment period, final assessments are conducted to evaluate changes in heart function and other health parameters.

    Participants may be asked to complete questionnaires about their symptoms and quality of life.

  7. Step 7

    Follow-up

    After completing the treatment phase, participants may have follow-up visits to monitor any long-term effects of the medication.

Who can join the trial?

6 criteria

  • Must be a male or female between the ages of 30 and 85 years old.
  • Must have been diagnosed with **heart failure** that shows symptoms at least 90 days before the screening visit.
  • Must be in **New York Heart Association (NYHA) functional class II or III**, which means experiencing some limitations in physical activity due to heart failure, at the screening visit.
  • Must be on a stable treatment plan for heart failure, following guidelines from recognized heart health organizations, for at least 4 weeks before the screening visit. This includes taking at least half of the maximum recommended dose of certain heart medications, if they can be tolerated.
  • Must have a **left ventricular ejection fraction (LVEF)** of 35% or less at the screening visit. This is a measure of how well the heart is pumping blood.
  • Must have a **serum N-terminal pro b-type natriuretic peptide (NT-pro-BNP)** level of 600 pg/mL or higher at the screening visit. If the person has certain heart rhythm issues like atrial fibrillation or atrial flutter, the level should be 900 pg/mL or higher. This is a blood test that helps assess heart failure.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of heart condition other than Heart Failure with Reduced Ejection Fraction cannot participate. This type of heart failure means the heart is not pumping as well as it should.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for specific age groups.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are important to ensure the safety and effectiveness of the study.
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Investigated drugs

JTT-861 is a medication being studied for its potential benefits in treating heart failure with reduced ejection fraction. This condition means the heart is not pumping blood as well as it should. The trial aims to see how effective, safe, and tolerable this medication is when taken over a period of 12 weeks. Researchers are also looking at how the body processes the medication during this time.

What is already known about the treatment

JTT-861 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating heart failure with reduced ejection fraction. It is in the Phase 2a stage of clinical research, where its efficacy, safety, and tolerability are being evaluated. The main therapeutic indication for JTT-861 is heart failure, specifically targeting patients with reduced ejection fraction. At the molecular level, JTT-861 works by modulating specific pathways involved in cardiac function, although the precise mechanism is still under investigation. It is classified pharmacologically as a potential treatment for heart failure, focusing on improving heart function and patient outcomes.

Investigated diseases

Heart Failure with Reduced Ejection Fraction – This condition occurs when the heart muscle is weakened and cannot pump blood efficiently, leading to a reduced ejection fraction. The ejection fraction is a measurement of how much blood the left ventricle pumps out with each contraction. As the disease progresses, patients may experience symptoms such as shortness of breath, fatigue, and fluid retention. The heart's ability to supply the body with adequate blood diminishes over time, which can affect physical activity and overall quality of life. The condition is often associated with structural changes in the heart, such as enlargement of the heart chambers. Management focuses on improving heart function and alleviating symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504835-42-00Protocol codeAT861-G-22-002Estimated enrolment476 patientsSponsorAkros Pharma Inc.

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