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Chronic Heart FailurePhase 2POWER-HFNCT06017609

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

A Phase 2 study testing JTT-861 Capsules in people with Chronic Heart Failure, run by Shionogi Inc. at 75 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 85 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
JTT-861 Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
314 participants
Where
75 sitesin 6 countries
Study dates
20 Dec 2023to 18 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

75 sites in 6 countries.

75 sites in 6 countries

United States20 sites

  • NextStage Clinical Research-Beaumont- (01)

    Beaumont, Texas, 77702

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429

  • Cypress Heart and Vascular Center

    Cypress, Texas, 77429

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Profound Research LLC

    Farmington Hills, Michigan, 48334

  • ASHA Clinical Research-Munster, LLC

    Hammond, Indiana, 46324

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • NextStage Clinical Research - (Kansas City [01])

    Kansas City, Missouri, 64114

  • Med Research of Florida

    Miami, Florida, 33186

  • Pharma Medical Innovation, Inc.

    Miami Lakes, Florida, 33014

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016

  • Affinity Health

    Park Ridge, Illinois, 60068

  • Arensia Exploratory Medicine Inc.

    Phoenix, Arizona, 85015

  • NextStage Clinical Research-Port Arthur-(02)

    Port Arthur, Texas, 77642

  • Onsite Clinical Solutions, LLC

    Rock Hill, South Carolina, 29732

  • Laurelton Heart Specialist P.C.

    Rosedale, New York, 11422

  • Sherman Clinical Research

    Sherman, Texas, 75092

  • Waco Cardiology Associates - NextStage Clinical Research

    Waco, Texas, 76712

  • Monroe Research, LLC

    West Monroe, Louisiana, 71291

Other trials in United States

Romania12 sites

  • Thera Card S.R.L

    Brasov, 500102

  • Spitalul Clinic Judetean De Urgenta Brasov

    Brasov, 500326

  • Spitalul Clinic De Urgență Sf. Pantelimon București

    Bucharest, 021659

  • Spitalul Universitar de Urgență București

    Bucharest, 050098

  • Mat Cord Biomedica SRL

    Buzău, 120133

  • Angiocare S.R.L.

    Cluj-Napoca, 400015

  • Cardio Med SRL

    Craiova, 200513

  • Spitalul Clinic Județean de Urgență Craiova

    Craiova, 200642

  • Cardio Med SRL

    Târgu Mureş, 540124

  • CMI Dr. Podoleanu Cristian

    Târgu Mureş, 540143

  • Spitalul Clinic Municipal de Urgenţă Timişoara

    Timișoara, 300024

  • Spitalul Clinic Municipal de Urgenţă Timişoara

    Timișoara, 300079

Other trials in Romania

Spain12 sites

  • Hospital Clínico Universitario de Santiago

    A Coruña, 15706

  • Hospital del Mar - Parc de Salut Mar

    Barcelona, 08003

  • Area Sanitaria De Ferrol - Hospital Arquitecto Marcide

    Ferrol, 15405

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

Bulgaria11 sites

  • Ambulatory for Specialized Outpatient Medical Care in Cardiology Individual Practice- Dr. Elena Dotcheva EOOD

    Burgas, 8000

  • Multiprofile Hospital for Active Treatment "Ivan Skenderov"

    Gotse Delchev, 2900

  • Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD

    Gotse Delchev, 2900

  • University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD

    Pleven, 5803

  • Multiprofile Hospital For Active Treatment Heart and Brain EAD

    Pleven, 5804

  • University Multiprofile Hospital For Active Treatment Saint Georgi EAD

    Plovdiv, 4002

  • Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD

    Sofia, 1415

  • Medical Center Hera EOOD

    Sofia, 1510

  • Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

  • Diagnostic Consultative Center Convex EOOD

    Sofia, 1680

  • University Multiprofile Hospital for Active Treatment. Sv Anna - Sofia AD

    Sofia, 1750

Other trials in Bulgaria

Poland11 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • American Heart of Poland S.A.

    Chrzanów, 32-500

  • American Heart of Poland S.A.

    Dąbrowa Górnicza, 41-300

  • Kardio Brynów Sp. z o.o.

    Katowice, 40-555

  • Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp.j.

    Kędzierzyn-Koźle, 47-200

  • Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego

    Lodz, 91-347

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-090

  • Trialmed CRS Piotrków Trybunalski

    Piotrkow Trybunalski, 97-300

  • NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus

    Sopot, 81-717

  • American Heart of Poland S.A.

    Tychy, 43-100

  • 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu

    Wroclaw, 53-114

Other trials in Poland

Czechia9 sites

  • MUDr. Libor Nechvatal s.r.o.

    Brno, 602 00

  • Centrum pro zdraví, s.r.o.

    Brno, 603 00

  • Vojenská nemocnice Brno

    Brno, 615 00

  • Fakultní nemocnice Brno

    Brno, 625 00

  • Edumed s.r.o.

    Broumov, 550 01

  • Edumed s.r.o.

    Hradec Králové, 500 02

  • Edumed s.r.o.

    Jaroměř, 551 01

  • Edumed s.r.o.

    Náchod, 547 01

  • Fakultní nemocnice Ostrava

    Ostrava-Poruba, 708 52

Other trials in Czechia

About this study

Official title: 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

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.

Being tested
JTT-861 Capsules, Placebo Capsules
Keywords
JTT-861, Efficacy, Safety, Tolerability, Chronic Heart Failure, HFrEF, Heart Failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JTT-861 CapsulesDrug

    Active drug capsules containing JTT-861

  • Placebo CapsulesDrug

    Placebo capsules matching in appearance to the active drug capsules

Study groups in NCT06017609
Study groupRoleWhat they receive
JTT-861 Dose 1ExperimentalJTT-861 Capsules Dose 1 orally once daily for 12 weeks
Receives: Drug: JTT-861 Capsules
JTT-861 Dose 2ExperimentalJTT-861 Capsules Dose 2 orally once daily for 12 weeks
Receives: Drug: JTT-861 Capsules
PlaceboExperimentalPlacebo Capsules orally once daily for 12 weeks
Receives: Drug: Placebo Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo)

    Measured: 12 Weeks

  2. Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo

    Measured: 12 Weeks

  3. Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo

    Measured: 12 Weeks

  4. Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo

    Measured: 12 Weeks

  5. Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values

    Measured: 12 Weeks

  6. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline

    General Scoring Guideline: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent

    Measured: 16 Weeks

  7. Number of subjects with treatment-emergent adverse events

    Measured: Up to 16 Weeks

  8. Trough plasma concentrations of JTT-861

    Measured: Weeks 4, 8 and 12

  9. Post-dose plasma concentrations of JTT-861

    Measured: Weeks 2, 4 and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start20 Dec 2023
  3. Primary completion18 May 2026
  4. Study completion18 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06017609
Sponsor's protocol ID
AT861-G-22-002
Acronym
POWER-HF
Status last verified
Sep 2026
First submitted
24 Aug 2023
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JTT-861 Capsules in people with Chronic Heart Failure, run by Shionogi Inc. at 75 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Romania, Spain, Bulgaria, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo) (time frame: 12 Weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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