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New heart failure pill shows promise in early trial

NCT ID NCT06017609

Disease control Sponsor: Akros Pharma Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called JTT-861 in 314 adults with chronic heart failure and reduced pumping ability. Participants took either the drug or a placebo once daily for 12 weeks, alongside their usual heart medications. The goal was to see if the drug improves heart function, reduces symptoms, and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JTT-861 capsules
What this could lead to
If it works, this could point toward a new daily pill to improve heart function and quality of life in people with chronic heart failure.
What could go wrong
This is an early Phase 2a trial with only 314 people, so results may not confirm benefit. The drug may cause side effects or fail to improve heart function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

314 people

The number who actually took part.

Started

Dec 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic heart failure

Contacts and locations

Locations

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

    Wroclaw, 53-114, Poland

  • ASHA Clinical Research-Munster, LLC

    Hammond, Indiana, 46324, United States

  • Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD

    Sofia, 1415, Bulgaria

  • Affinity Health

    Park Ridge, Illinois, 60068, United States

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

    Burgas, 8000, Bulgaria

  • American Heart of Poland S.A.

    Chrzanów, 32-500, Poland

  • American Heart of Poland S.A.

    Dąbrowa Górnicza, 41-300, Poland

  • American Heart of Poland S.A.

    Tychy, 43-100, Poland

  • Angiocare S.R.L.

    Cluj-Napoca, 400015, Romania

  • Area Sanitaria De Ferrol - Hospital Arquitecto Marcide

    Ferrol, 15405, Spain

  • Arensia Exploratory Medicine Inc.

    Phoenix, Arizona, 85015, United States

  • CMI Dr. Podoleanu Cristian

    Târgu Mureş, 540143, Romania

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011, United States

  • Cardio Med SRL

    Craiova, 200513, Romania

  • Cardio Med SRL

    Târgu Mureş, 540124, Romania

  • Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp.j.

    Kędzierzyn-Koźle, 47-200, Poland

  • Centrum pro zdraví, s.r.o.

    Brno, 603 00, Czechia

  • Cypress Heart and Vascular Center

    Cypress, Texas, 77429, United States

  • Diagnostic Consultative Center Convex EOOD

    Sofia, 1680, Bulgaria

  • Edumed s.r.o.

    Broumov, 550 01, Czechia

  • Edumed s.r.o.

    Hradec Králové, 500 02, Czechia

  • Edumed s.r.o.

    Jaroměř, 551 01, Czechia

  • Edumed s.r.o.

    Náchod, 547 01, Czechia

  • Fakultní nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultní nemocnice Ostrava

    Ostrava-Poruba, 708 52, Czechia

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Hospital Clínico Universitario de Santiago

    A Coruña, 15706, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital del Mar - Parc de Salut Mar

    Barcelona, 08003, Spain

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012, United States

  • Kardio Brynów Sp. z o.o.

    Katowice, 40-555, Poland

  • Laurelton Heart Specialist P.C.

    Rosedale, New York, 11422, United States

  • MUDr. Libor Nechvatal s.r.o.

    Brno, 602 00, Czechia

  • Mat Cord Biomedica SRL

    Buzău, 120133, Romania

  • Med Research of Florida

    Miami, Florida, 33186, United States

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Monroe Research, LLC

    West Monroe, Louisiana, 71291, United States

  • Multiprofile Hospital For Active Treatment Heart and Brain EAD

    Pleven, 5804, Bulgaria

  • Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD

    Gotse Delchev, 2900, Bulgaria

  • Multiprofile Hospital for Active Treatment "Ivan Skenderov"

    Gotse Delchev, 2900, Bulgaria

  • Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527, Bulgaria

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

    Sopot, 81-717, Poland

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429, United States

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

    Kansas City, Missouri, 64114, United States

  • NextStage Clinical Research-Beaumont- (01)

    Beaumont, Texas, 77702, United States

  • NextStage Clinical Research-Port Arthur-(02)

    Port Arthur, Texas, 77642, United States

  • Onsite Clinical Solutions, LLC

    Rock Hill, South Carolina, 29732, United States

  • Pharma Medical Innovation, Inc.

    Miami Lakes, Florida, 33014, United States

  • Profound Research LLC

    Farmington Hills, Michigan, 48334, United States

  • Sherman Clinical Research

    Sherman, Texas, 75092, United States

  • Spitalul Clinic De Urgență Sf. Pantelimon București

    Bucharest, 021659, Romania

  • Spitalul Clinic Judetean De Urgenta Brasov

    Brasov, 500326, Romania

  • Spitalul Clinic Județean de Urgență Craiova

    Craiova, 200642, Romania

  • Spitalul Clinic Municipal de Urgenţă Timişoara

    Timișoara, 300024, Romania

  • Spitalul Clinic Municipal de Urgenţă Timişoara

    Timișoara, 300079, Romania

  • Spitalul Universitar de Urgență București

    Bucharest, 050098, Romania

  • Thera Card S.R.L

    Brasov, 500102, Romania

  • Trialmed CRS Piotrków Trybunalski

    Piotrkow Trybunalski, 97-300, Poland

  • University Multiprofile Hospital For Active Treatment Saint Georgi EAD

    Plovdiv, 4002, Bulgaria

  • University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD

    Pleven, 5803, Bulgaria

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

    Sofia, 1750, Bulgaria

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-090, Poland

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276, Poland

  • Vojenská nemocnice Brno

    Brno, 615 00, Czechia

  • Waco Cardiology Associates - NextStage Clinical Research

    Waco, Texas, 76712, United States

  • Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego

    Lodz, 91-347, Poland

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Other studies related to the condition(s) this trial covers.