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

Last updated: September 21, 2026
Sponsor: Akros Pharma Inc.
Overall Status: Completed

Phase

2

Condition

Hyponatremia

Chest Pain

Congestive Heart Failure

Treatment

JTT-861 Capsules

Placebo Capsules

Clinical Study ID

NCT06017609
AT861-G-22-002
  • Ages 30-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a clinical diagnosis of symptomatic heart failure (HF) ≥90 days prior to theScreening Visit;

  • Is in New York Heart Association (NYHA) functional class II or III at the ScreeningVisit;

  • Is on stable, guideline-directed therapy for HF, consistent with American HeartAssociation (AHA), American College of Cardiology (ACC), Heart Failure Society ofAmerica (HFSA) or European Society of Cardiology (ESC) guidelines for ≥4 weeks priorto the Screening Visit (with at least half of maximal labeled dose ofrenin-angiotensin-aldosterone system (RAAS) inhibitors and β-blockers, iftolerated);

  • 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 theScreening Visit.

Exclusion

Exclusion Criteria:

  • Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable anginawithin 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 surgerywithin 90 days prior to the Screening Visit or planned cardiovascular surgery duringthe study through the Follow-up Visit);

  • Has started cardiac resynchronization therapy (CRT) within 90 days prior to theScreening Visit or has planned CRT during the study through the Follow-up Visit;

  • Has clinically significant congenital heart disease, active myocarditis orconstrictive 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 glomerularfiltration rate [eGFR] <30 mL/min/1.73 m2 calculated by the Chronic Kidney DiseaseEpidemiology Collaboration [CKD-EPI] creatinine equation) at the Screening Visit.

Study Design

Total Participants: 314
Treatment Group(s): 2
Primary Treatment: JTT-861 Capsules
Phase: 2
Study Start date:
December 20, 2023
Estimated Completion Date:
May 18, 2026

Connect with a study center

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

    Burgas, 8000
    Bulgaria

    Site Not Available

  • Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD

    Gotse Delchev, 2900
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment "Ivan Skenderov"

    Gotse Delchev, 2900
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment "Ivan Skenderov"

    Gotse Delchev 731108, 2900
    Bulgaria

    Site Not Available

  • Multiprofile Hospital For Active Treatment Heart and Brain EAD

    Pleven, 5804
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD

    Pleven, 5803
    Bulgaria

    Site Not Available

  • Multiprofile Hospital For Active Treatment Heart and Brain EAD

    Pleven 728203, 5804
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital For Active Treatment Saint Georgi EAD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD

    Sofia, 1415
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Convex EOOD

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Medical Center Hera EOOD

    Sofia, 1510
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527
    Bulgaria

    Site Not Available

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

    Sofia, 1750
    Bulgaria

    Site Not Available

  • Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD

    Sofia 727011, 1415
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Convex EOOD

    Sofia 727011, 1680
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia 727011, 1527
    Bulgaria

    Site Not Available

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

    Sofia 727011, 1750
    Bulgaria

    Site Not Available

  • Fakultní nemocnice Brno

    Brno, 625 00
    Czech Republic

    Active - Recruiting

  • Fakultní nemocnice u sv. Anny v Brně

    Brno, 602 00
    Czech Republic

    Active - Recruiting

  • Vojenská nemocnice Brno

    Brno, 615 00
    Czech Republic

    Active - Recruiting

  • Fakultní nemocnice Ostrava

    Ostrava-Poruba, 708 52
    Czech Republic

    Active - Recruiting

  • Centrum pro zdraví, s.r.o.

    Brno, 603 00
    Czechia

    Site Not Available

  • Fakultní nemocnice Brno

    Brno, 625 00
    Czechia

    Site Not Available

  • MUDr. Libor Nechvatal s.r.o.

    Brno, 602 00
    Czechia

    Site Not Available

  • Vojenská nemocnice Brno

    Brno, 615 00
    Czechia

    Site Not Available

  • Centrum pro zdraví, s.r.o.

    Brno 3078610, 603 00
    Czechia

    Site Not Available

  • MUDr. Libor Nechvatal s.r.o.

    Brno 3078610, 602 00
    Czechia

    Site Not Available

  • Vojenská nemocnice Brno

    Brno 3078610, 615 00
    Czechia

    Site Not Available

  • Edumed s.r.o.

    Broumov, 550 01
    Czechia

    Site Not Available

  • Edumed s.r.o.

    Hradec Králové, 500 02
    Czechia

    Site Not Available

  • Edumed s.r.o.

    Jaroměř, 551 01
    Czechia

    Site Not Available

  • Edumed s.r.o.

    Náchod, 547 01
    Czechia

    Site Not Available

  • Fakultní nemocnice Ostrava

    Ostrava-Poruba, 708 52
    Czechia

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276
    Poland

    Site Not Available

  • American Heart of Poland S.A.

    Chrzanów, 32-500
    Poland

    Site Not Available

  • American Heart of Poland S.A.

    Dąbrowa Górnicza, 41-300
    Poland

    Site Not Available

  • Kardio Brynów Sp. z o.o.

    Katowice, 40-555
    Poland

    Site Not Available

  • Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp.j.

    Kędzierzyn-Koźle, 47-200
    Poland

    Site Not Available

  • Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego

    Lodz, 91-347
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-090
    Poland

    Site Not Available

  • Trialmed CRS Piotrków Trybunalski

    Piotrkow Trybunalski, 97-300
    Poland

    Site Not Available

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

    Sopot, 81-717
    Poland

    Site Not Available

  • American Heart of Poland S.A.

    Tychy, 43-100
    Poland

    Site Not Available

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

    Wroclaw, 53-114
    Poland

    Site Not Available

  • Spitalul Clinic Judetean De Urgenta Brasov

    Brasov, 500326
    Romania

    Site Not Available

  • Thera Card S.R.L

    Brasov, 500102
    Romania

    Site Not Available

  • Thera Card S.R.L

    Brasov 683844, 500102
    Romania

    Site Not Available

  • Spitalul Clinic De Urgență Sf. Pantelimon București

    Bucharest, 021659
    Romania

    Site Not Available

  • Spitalul Universitar de Urgență București

    Bucharest, 050098
    Romania

    Site Not Available

  • Spitalul Clinic De Urgență Sf. Pantelimon București

    Bucharest 683506, 021659
    Romania

    Site Not Available

  • Spitalul Clinic De Urgență Sf. Pantelimon București

    București, 021659
    Romania

    Active - Recruiting

  • Mat Cord Biomedica SRL

    Buzău, 120133
    Romania

    Site Not Available

  • Angiocare S.R.L.

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Cardio Med SRL

    Craiova, 200513
    Romania

    Site Not Available

  • Spitalul Clinic Județean de Urgență Craiova

    Craiova, 200642
    Romania

    Site Not Available

  • Cardio Med SRL

    Craiova 680332, 200513
    Romania

    Site Not Available

  • Spitalul Clinic Municipal de Urgenţă Timişoara

    Timișoara, 300024
    Romania

    Site Not Available

  • Spitalul Clinic Municipal de Urgenţă Timişoara

    Timișoara 665087, 300024
    Romania

    Site Not Available

  • CMI Dr. Podoleanu Cristian

    Târgu Mureş, 540143
    Romania

    Site Not Available

  • Cardio Med SRL

    Târgu Mureş, 540124
    Romania

    Site Not Available

  • Cardio Med SRL

    Târgu Mureş 665004, 540124
    Romania

    Site Not Available

  • Cardio Med SRL

    Târgu Mureș, 540124
    Romania

    Active - Recruiting

  • Hospital Clínico Universitario de Santiago

    A Coruña, 15706
    Spain

    Site Not Available

  • Hospital del Mar - Parc de Salut Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Area Sanitaria De Ferrol - Hospital Arquitecto Marcide

    Ferrol, 15405
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid 3117735, 28222
    Spain

    Site Not Available

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Seville, 41009
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politècnic La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Arensia Exploratory Medicine Inc.

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Crystal River, Florida 34429
    United States

    Site Not Available

  • Indago Research & Health Center, Inc.

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Med Research of Florida

    Miami, Florida 33186
    United States

    Site Not Available

  • Floridian Clinical Research

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Pharma Medical Innovation, Inc.

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Pharma Medical Innovation, Inc.

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Site Not Available

  • Affinity Health

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • ASHA Clinical Research-Munster, LLC

    Hammond, Indiana 46324
    United States

    Site Not Available

  • Monroe Research, LLC

    West Monroe, Louisiana 71291
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Profound Research LLC

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

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

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Laurelton Heart Specialist P.C.

    Rosedale, New York 11422
    United States

    Site Not Available

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • Onsite Clinical Solutions, LLC

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • NextStage Clinical Research-Beaumont- (01)

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Cypress Heart and Vascular Center

    Cypress, Texas 77429
    United States

    Site Not Available

  • NextStage Clinical Research-Port Arthur-(02)

    Port Arthur, Texas 77642
    United States

    Site Not Available

  • Sherman Clinical Research

    Sherman, Texas 75092
    United States

    Site Not Available

  • Waco Cardiology Associates - NextStage Clinical Research

    Waco, Texas 76712
    United States

    Site Not Available

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