Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
NCT ID: NCT06017609
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2023-12-20
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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JTT-861 Dose 1
JTT-861 Capsules Dose 1 orally once daily for 12 weeks
JTT-861 Capsules
Active drug capsules containing JTT-861
JTT-861 Dose 2
JTT-861 Capsules Dose 2 orally once daily for 12 weeks
JTT-861 Capsules
Active drug capsules containing JTT-861
Placebo
Placebo Capsules orally once daily for 12 weeks
Placebo Capsules
Placebo capsules matching in appearance to the active drug capsules
Interventions
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JTT-861 Capsules
Active drug capsules containing JTT-861
Placebo Capsules
Placebo capsules matching in appearance to the active drug capsules
Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
85 Years
ALL
No
Sponsors
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ICON Clinical Research
INDUSTRY
Akros Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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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
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
University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD
Pleven, , Bulgaria
Multiprofile Hospital For Active Treatment Heart and Brain EAD
Pleven, , Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv, , Bulgaria
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
Sofia, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, , Bulgaria
Diagnostic Consultative Center Convex EOOD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment. Sv Anna - Sofia AD
Sofia, , Bulgaria
MUDr. Libor Nechvatal s.r.o.
Brno, , Czechia
Centrum pro zdraví, s.r.o.
Brno, , Czechia
Vojenská nemocnice Brno
Brno, , Czechia
Fakultní nemocnice Brno
Brno, , Czechia
Edumed s.r.o.
Broumov, , Czechia
Edumed s.r.o.
Hradec Králové, , Czechia
Edumed s.r.o.
Jaroměř, , Czechia
Edumed s.r.o.
Náchod, , Czechia
Fakultní nemocnice Ostrava
Ostrava-Poruba, , Czechia
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
American Heart of Poland S.A.
Chrzanów, , Poland
American Heart of Poland S.A.
Dąbrowa Górnicza, , Poland
Kardio Brynów Sp. z o.o.
Katowice, , Poland
Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp.j.
Kędzierzyn-Koźle, , Poland
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Lodz, , Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, , Poland
Trialmed CRS Piotrków Trybunalski
Piotrkow Trybunalski, , Poland
NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus
Sopot, , Poland
American Heart of Poland S.A.
Tychy, , Poland
4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu
Wroclaw, , Poland
Thera Card S.R.L
Brasov, , Romania
Spitalul Clinic Judetean De Urgenta Brasov
Brasov, , Romania
Spitalul Clinic De Urgență Sf. Pantelimon București
Bucharest, , Romania
Spitalul Universitar de Urgență București
Bucharest, , Romania
Mat Cord Biomedica SRL
Buzău, , Romania
Angiocare S.R.L.
Cluj-Napoca, , Romania
Cardio Med SRL
Craiova, , Romania
Spitalul Clinic Județean de Urgență Craiova
Craiova, , Romania
Cardio Med SRL
Târgu Mureş, , Romania
CMI Dr. Podoleanu Cristian
Târgu Mureş, , Romania
Spitalul Clinic Municipal de Urgenţă Timişoara
Timișoara, , Romania
Spitalul Clinic Municipal de Urgenţă Timişoara
Timișoara, , Romania
Hospital Clínico Universitario de Santiago
A Coruña, , Spain
Hospital del Mar - Parc de Salut Mar
Barcelona, , Spain
Area Sanitaria De Ferrol - Hospital Arquitecto Marcide
Ferrol, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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AT861-G-22-002
Identifier Type: -
Identifier Source: org_study_id
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