Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects with Heart Failure with Reduced Ejection Fraction

Description

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable, guideline-directed medical therapy for heart failure.

Conditions

Chronic Heart Failure

Study Overview

Study Details

Study overview

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable, guideline-directed medical therapy for heart failure.

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

Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects with Heart Failure with Reduced Ejection Fraction

Condition
Chronic Heart Failure
Intervention / Treatment

-

Contacts and Locations

Crystal River

Nature Coast Clinical Research, Crystal River, Florida, United States, 34429

Hialeah

Indago Research & Health Center, Inc., Hialeah, Florida, United States, 33012

Miami Lakes

Pharma Medical Innovation, Inc., Miami Lakes, Florida, United States, 33014

Tamarac

D and H Tamarac Research Center, LLC, Tamarac, Florida, United States, 33321

Park Ridge

Affinity Health, Park Ridge, Illinois, United States, 60068

Hammond

ASHA Clinical Research-Munster, LLC, Hammond, Indiana, United States, 46324

Alexandria

Cambridge Medical Trials, Alexandria, Louisiana, United States, 71301

West Monroe

Monroe Research, LLC, West Monroe, Louisiana, United States, 71291

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Rosedale

Laurelton Heart Specialist P.C., Rosedale, New York, United States, 11422

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

30 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Akros Pharma Inc.,

Study Record Dates

2025-09