Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
Completed · Phase 2 · Has a placebo group
Conditions studied: Chronic Heart Failure
In brief
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.
Key facts
- Study ID
- NCT06017609
- Run by
- Akros Pharma Inc.
- People needed
- 314
- Starts
- 2023-12-20
- Expected to finish
- 2026-05-18
- Last updated by the study team
- 2026-05-22
Who can join
Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Arensia Exploratory Medicine Inc. — Phoenix, Arizona, United States
- Nature Coast Clinical Research — Crystal River, Florida, United States
- Indago Research & Health Center, Inc. — Hialeah, Florida, United States
- Angiocare S.R.L. — Cluj-Napoca, Romania
- Med Research of Florida — Miami, Florida, United States
- Pharma Medical Innovation, Inc. — Miami Lakes, Florida, United States
- Floridian Clinical Research — Miami Lakes, Florida, United States
- Affinity Health — Park Ridge, Illinois, United States
- ASHA Clinical Research-Munster, LLC — Hammond, Indiana, United States
- Monroe Research, LLC — West Monroe, Louisiana, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Profound Research LLC — Farmington Hills, Michigan, United States
- NextStage Clinical Research - (Kansas City [01]) — Kansas City, Missouri, United States
- Laurelton Heart Specialist P.C. — Rosedale, New York, United States
- Capital Area Research, LLC — Camp Hill, Pennsylvania, United States
- Onsite Clinical Solutions, LLC — Rock Hill, South Carolina, United States
- NextStage Clinical Research-Beaumont- (01) — Beaumont, Texas, United States
- Cypress Heart and Vascular Center — Cypress, Texas, United States
- NextStage Clinical Research-Port Arthur-(02) — Port Arthur, Texas, United States
- Sherman Clinical Research — Sherman, Texas, United States
- Waco Cardiology Associates - NextStage Clinical Research — Waco, Texas, United States
- Ambulatory for Specialized Outpatient Medical Care in Cardiology Individual Practice- Dr. Elena Dotcheva EOOD — Burgas, Bulgaria
- Multiprofile Hospital for Active Treatment "Ivan Skenderov" — Gotse Delchev, Bulgaria
- Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD — Gotse Delchev, Bulgaria
- Cardio Med SRL — Craiova, Romania
Full record on ClinicalTrials.gov
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