Home › Trials › NCT06017609

Evaluating a new treatment for heart failure with reduced ejection fraction

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of JTT-861 Administered for 12 Weeks in Subjects With Heart Failure With Reduced Ejection Fraction

Phase 2 Interventional Akros Pharma Inc. · NCT06017609

This study is testing a new daily medication called JTT-861 to see if it can improve heart function and help people with heart failure and reduced ejection fraction feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment300 (estimated)
Ages30 Years to 85 Years
SexAll
SponsorAkros Pharma Inc. Industry-sponsored
Locations53 sites (Crystal River, Florida and 52 other locations)
Trial IDNCT06017609 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, tolerability, and pharmacokinetics of JTT-861, a new medication, administered once daily for 12 weeks in patients with heart failure with reduced ejection fraction (HFrEF). Participants must be on stable, guideline-directed medical therapy for heart failure prior to enrollment. The study aims to determine how well JTT-861 works compared to a placebo in improving heart function and patient outcomes. It includes a specific focus on patients with symptomatic heart failure and reduced ejection fraction.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with symptomatic heart failure for at least 90 days, in NYHA functional class II or III, and on stable heart failure therapy.

Not a fit: Patients with recent acute myocardial infarction or unstable angina may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of heart failure with reduced ejection fraction, leading to better patient outcomes.

How similar studies have performed: Other studies have shown promise in similar approaches for treating heart failure, but the specific efficacy of JTT-861 is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has a clinical diagnosis of symptomatic heart failure (HF) ≥90 days prior to the Screening Visit;
* Is in New York Heart Association (NYHA) functional class II or III at the Screening Visit;
* Is on stable, guideline-directed therapy for HF, consistent with American Heart Association (AHA), American College of Cardiology (ACC), Heart Failure Society of America (HFSA) or European Society of Cardiology (ESC) guidelines for ≥4 weeks prior to the Screening Visit (with at least half of maximal labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors and β-blockers, if tolerated);
* Has left ventricular ejection fraction (LVEF) ≤35% at the Screening Visit;
* Has a serum N-terminal pro b-type natriuretic peptide (NT-pro-BNP) level ≥600 pg/mL (or ≥900 pg/mL if the subject has atrial fibrillation or atrial flutter) at the Screening Visit.

Exclusion Criteria:

* Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable angina within 90 days prior to the Screening Visit;
* Has a history of coronary revascularization (percutaneous coronary intervention \[PCI\] and/or coronary artery bypass graft \[CABG\]) or other cardiovascular surgery within 90 days prior to the Screening Visit or planned cardiovascular surgery during the study through the Follow-up Visit);
* Has started cardiac resynchronization therapy (CRT) within 90 days prior to the Screening Visit or has planned CRT during the study through the Follow-up Visit;
* Has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis;
* Has current acute decompensated HF requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the Screening Visit;
* Has clinically significant chronic renal insufficiency (i.e., estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] creatinine equation) at the Screening Visit.

Where this trial is running

Crystal River, Florida and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Heart FailureJTT-861EfficacySafetyTolerabilityHFrEFHeart Failure
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.