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.
- Diseases
- Heart failure
- 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
Sites (75)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASIMPKIP D-R Elena Docheva EOOD Coordinator of this site? Confirm its status | Burgas | Bulgaria | Completed |
| Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD Coordinator of this site? Confirm its status | Gotse Delchev | Bulgaria | Completed |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| Multi-profile Hospital for Active Treatment Heart and Brain EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| University Hospital St. Anna Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| Centrum pro zdravi s.r.o. Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Completed |
| MUDr. Libor Nechvatal s.r.o. Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Completed |
| Vojenska Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Zidenice | Czechia | Completed |
| Edumed s.r.o. Coordinator of this site? Confirm its status | Broumov | Czechia | Completed |
| Edumed s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Completed |
| EDUMED s.r.o. Coordinator of this site? Confirm its status | Jaroměř | Czechia | Completed |
| Fakultni Nemocnice Ostrava Coordinator of this site? Confirm its status | Poruba | Czechia | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Area Sanitaria De Ferrol Coordinator of this site? Confirm its status | Ferrol | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| American Heart of Poland S.A. Coordinator of this site? Confirm its status | Chrzanów | Poland | Completed |
| American Heart of Poland S.A. Coordinator of this site? Confirm its status | Dąbrowa Górnicza | Poland | Completed |
| Kardio Brynów Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp.j. Coordinator of this site? Confirm its status | Kędzierzyn-Koźle | Poland | Completed |
| Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Trialmed Sp. z o. o. Coordinator of this site? Confirm its status | Piotrkow Trybunalski | Poland | Completed |
| Clinmedica Research sp. z o.o. Coordinator of this site? Confirm its status | Skierniewice | Poland | Completed |
| NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus Coordinator of this site? Confirm its status | Sopot | Poland | Completed |
| American Heart of Poland S.A. Coordinator of this site? Confirm its status | Tychy | Poland | Completed |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Spitalul Clinic Judetean de Urgenta Brasov Coordinator of this site? Confirm its status | Brasov | Romania | Completed |
| Thera Card S.R.L Coordinator of this site? Confirm its status | Brasov | Romania | Completed |
| Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Completed |
| Spitalul Universitar de Urgență București Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Spitalul Clinic De Urgență Sf. Pantelimon București Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Mat Cord Biomedica S.R.L. Coordinator of this site? Confirm its status | Buzău | Romania | Completed |
| Angiocare S.R.L. Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Cardio Med S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Spitalul Clinic Județean de Urgență Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| CMI Dr. Podoleanu Cristian Coordinator of this site? Confirm its status | Jud.Mures | Romania | Completed |
| Cardio Med S.R.L. Coordinator of this site? Confirm its status | Targu | Romania | Completed |
| Spitalul Clinic Municipal De Urgenta Timisoara Coordinator of this site? Confirm its status | Timisoara | Romania | Completed |
| NextStage Clinical Research-Beaumont- (01) Coordinator of this site? Confirm its status | Beaumont | United States | Unknown status |
| Capital Area Research, LLC Coordinator of this site? Confirm its status | Camp Hill | United States | Unknown status |
| Nature Coast Clinical Research Coordinator of this site? Confirm its status | Crystal River | United States | Unknown status |
| Cypress Heart and Vascular Center Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Profound Research, LLC Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| ASHA Clinical Research-Munster, LLC Coordinator of this site? Confirm its status | Hammond | United States | Unknown status |
| Indago Research & Health Center, Inc Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| NextStage Clinical Research - (Kansas City [01]) Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Med Research of Florida Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Pharma Medical Innovation, Inc. Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Floridian Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Affinity Health Coordinator of this site? Confirm its status | Park Ridge | United States | Unknown status |
| Arensia Exploratory Medicine Inc. Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| NextStage Clinical Research-Port Arthur-(02) Coordinator of this site? Confirm its status | Port Arthur | United States | Unknown status |
| Onsite Clinical Solutions, LLC Coordinator of this site? Confirm its status | Rock Hill | United States | Unknown status |
| Laurelton Heart Specialist P.C. Coordinator of this site? Confirm its status | Rosedale | United States | Unknown status |
| Sherman Clinical Research Coordinator of this site? Confirm its status | Sherman | United States | Unknown status |
| Waco Cardiology Associates - NextStage Clinical Research Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
| Monroe Research, LLC Coordinator of this site? Confirm its status | West Monroe | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.