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NCT06017609CompletedPhase 2

Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With 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

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
314 (actual)
First submitted
24 Aug 2023
Start date
20 Dec 2023
Primary completion date
18 May 2026
Lead sponsor
Shionogi Inc.
NCT number
NCT06017609
EU CT number
2023-504835-42-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 314
  • From 20 Dec 2023 to the primary completion date, 18 May 2026
  • 75 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 current acute decompensated HF requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the Screening Visit;

Other illness

  • Has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis;

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 30 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (75)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ASIMPKIP D-R Elena Docheva EOOD
Coordinator of this site? Confirm its status
BurgasBulgariaCompleted
Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD
Coordinator of this site? Confirm its status
Gotse DelchevBulgariaCompleted
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
Coordinator of this site? Confirm its status
PlevenBulgariaCompleted
Multi-profile Hospital for Active Treatment Heart and Brain EAD
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PlevenBulgariaCompleted
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
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PlovdivBulgariaCompleted
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
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SofiaBulgariaCompleted
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
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SofiaBulgariaCompleted
University Hospital St. Anna
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SofiyaBulgariaCompleted
Medical Center Hera EOOD
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SofiyaBulgariaCompleted
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaCompleted
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Centrum pro zdravi s.r.o.
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Brno-StredCzechiaCompleted
MUDr. Libor Nechvatal s.r.o.
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Brno-StredCzechiaCompleted
Vojenska Nemocnice Brno
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Brno-ZideniceCzechiaCompleted
Edumed s.r.o.
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BroumovCzechiaCompleted
Edumed s.r.o.
Coordinator of this site? Confirm its status
Hradec KrálovéCzechiaCompleted
EDUMED s.r.o.
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JaroměřCzechiaCompleted
Fakultni Nemocnice Ostrava
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PorubaCzechiaCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Area Sanitaria De Ferrol
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FerrolSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
American Heart of Poland S.A.
Coordinator of this site? Confirm its status
ChrzanówPolandCompleted
American Heart of Poland S.A.
Coordinator of this site? Confirm its status
Dąbrowa GórniczaPolandCompleted
Kardio Brynów Sp. z o.o.
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KatowicePolandCompleted
Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp.j.
Coordinator of this site? Confirm its status
Kędzierzyn-KoźlePolandCompleted
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
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LodzPolandCompleted
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandCompleted
Trialmed Sp. z o. o.
Coordinator of this site? Confirm its status
Piotrkow TrybunalskiPolandCompleted
Clinmedica Research sp. z o.o.
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SkierniewicePolandCompleted
NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus
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SopotPolandCompleted
American Heart of Poland S.A.
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TychyPolandCompleted
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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WroclawPolandCompleted
Spitalul Clinic Judetean de Urgenta Brasov
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BrasovRomaniaCompleted
Thera Card S.R.L
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BrasovRomaniaCompleted
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
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BrasovRomaniaCompleted
Spitalul Universitar de Urgență București
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BucharestRomaniaCompleted
Spitalul Clinic De Urgență Sf. Pantelimon București
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BucharestRomaniaCompleted
Mat Cord Biomedica S.R.L.
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BuzăuRomaniaCompleted
Angiocare S.R.L.
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Cluj-NapocaRomaniaCompleted
Cardio Med S.R.L.
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CraiovaRomaniaCompleted
Spitalul Clinic Județean de Urgență Craiova
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CraiovaRomaniaCompleted
CMI Dr. Podoleanu Cristian
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Jud.MuresRomaniaCompleted
Cardio Med S.R.L.
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TarguRomaniaCompleted
Spitalul Clinic Municipal De Urgenta Timisoara
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TimisoaraRomaniaCompleted
NextStage Clinical Research-Beaumont- (01)
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BeaumontUnited StatesUnknown status
Capital Area Research, LLC
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Camp HillUnited StatesUnknown status
Nature Coast Clinical Research
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Crystal RiverUnited StatesUnknown status
Cypress Heart and Vascular Center
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CypressUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Profound Research, LLC
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Farmington HillsUnited StatesUnknown status
ASHA Clinical Research-Munster, LLC
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HammondUnited StatesUnknown status
Indago Research & Health Center, Inc
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HialeahUnited StatesUnknown status
NextStage Clinical Research - (Kansas City [01])
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Kansas CityUnited StatesUnknown status
Med Research of Florida
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MiamiUnited StatesUnknown status
Pharma Medical Innovation, Inc.
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Miami LakesUnited StatesUnknown status
Floridian Clinical Research
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Miami LakesUnited StatesUnknown status
Affinity Health
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Park RidgeUnited StatesUnknown status
Arensia Exploratory Medicine Inc.
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PhoenixUnited StatesUnknown status
NextStage Clinical Research-Port Arthur-(02)
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Port ArthurUnited StatesUnknown status
Onsite Clinical Solutions, LLC
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Rock HillUnited StatesUnknown status
Laurelton Heart Specialist P.C.
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RosedaleUnited StatesUnknown status
Sherman Clinical Research
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ShermanUnited StatesUnknown status
Waco Cardiology Associates - NextStage Clinical Research
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WacoUnited StatesUnknown status
Monroe Research, LLC
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West MonroeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.