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

Last updated: April 18, 2025
Sponsor: Akros Pharma Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

Placebo Capsules

JTT-861 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: 300
Treatment Group(s): 2
Primary Treatment: Placebo Capsules
Phase: 2
Study Start date:
December 20, 2023
Estimated Completion Date:
February 28, 2027

Connect with a study center

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

    Burgas, 8000
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital For Active Treatment Heart and Brain EAD

    Pleven, 5804
    Bulgaria

    Active - Recruiting

  • University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD

    Pleven, 5803
    Bulgaria

    Active - Recruiting

  • Diagnostic Consultative Center Convex EOOD

    Sofia, 1680
    Bulgaria

    Active - Recruiting

  • Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527
    Bulgaria

    Active - Recruiting

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

    Sofia, 1750
    Bulgaria

    Active - Recruiting

  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

  • Medicus Services s.r.o.

    Brandýs nad Labem, 250 01
    Czech Republic

    Site Not Available

  • Centrum pro zdraví, s.r.o.

    Brno, 603 00
    Czech Republic

    Active - Recruiting

  • 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

  • Edumed s.r.o.

    Náchod, 547 01
    Czech Republic

    Active - Recruiting

  • Fakultní nemocnice Ostrava

    Ostrava-Poruba, 708 52
    Czech Republic

    Active - Recruiting

  • Kardio Brynów Sp. z o.o.

    Katowice, 40-555
    Poland

    Active - Recruiting

  • Trialmed CRS Piotrków Trybunalski

    Piotrków Trybunalski, 97-300
    Poland

    Active - Recruiting

  • Clinmedica Research Sp. z o.o.

    Skierniewice, 96-100
    Poland

    Site Not Available

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

    Sopot, 81-717
    Poland

    Active - Recruiting

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

    Wrocław, 53-114
    Poland

    Active - Recruiting

  • Spitalul Clinic Judetean De Urgenta Brasov

    Brasov, 500326
    Romania

    Active - Recruiting

  • Thera Card S.R.L

    Brasov, 500102
    Romania

    Active - Recruiting

  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

    Brașov, 500283
    Romania

    Site Not Available

  • Spitalul Clinic De Urgență Sf. Pantelimon București

    București, 021659
    Romania

    Active - Recruiting

  • Spitalul Universitar de Urgență București

    București, 050098
    Romania

    Active - Recruiting

  • Mat Cord Biomedica SRL

    Buzău, 120133
    Romania

    Active - Recruiting

  • Angiocare S.R.L.

    Cluj-Napoca, 400015
    Romania

    Active - Recruiting

  • Cardio Med SRL

    Craiova, 200513
    Romania

    Active - Recruiting

  • Spitalul Clinic Județean de Urgență Craiova

    Craiova, 200642
    Romania

    Active - Recruiting

  • CMI Dr. Podoleanu Cristian

    Târgu Mureș, 540143
    Romania

    Active - Recruiting

  • Cardio Med SRL

    Târgu Mureș, 540124
    Romania

    Active - Recruiting

  • Hospital Clínico Universitario de Santiago

    A Coruña, 15706
    Spain

    Active - Recruiting

  • Hospital del Mar - Parc de Salut Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Area Sanitaria De Ferrol - Hospital Arquitecto Marcide

    Ferrol, 15405
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Nature Coast Clinical Research

    Crystal River, Florida 34429
    United States

    Active - Recruiting

  • Indago Research & Health Center, Inc.

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Pharma Medical Innovation, Inc.

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • D and H Tamarac Research Center, LLC

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Accel Research Site Network - Cardiology Care Clinic

    Eatonton, Georgia 31024
    United States

    Site Not Available

  • Affinity Health

    Park Ridge, Illinois 60068
    United States

    Active - Recruiting

  • ASHA Clinical Research-Munster, LLC

    Hammond, Indiana 46324
    United States

    Active - Recruiting

  • Cambridge Medical Trials

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Monroe Research, LLC

    West Monroe, Louisiana 71291
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Marian David, MD, PC

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Laurelton Heart Specialist P.C.

    Rosedale, New York 11422
    United States

    Active - Recruiting

  • Medication Management, LLC

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Onsite Clinical Solutions, LLC

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

  • NextStage Clinical Research-Beaumont- (01)

    Beaumont, Texas 77702
    United States

    Active - Recruiting

  • Prime Revival Research Institute, LLC

    Coppell, Texas 75019
    United States

    Site Not Available

  • Cypress Heart and Vascular Center

    Cypress, Texas 77429
    United States

    Active - Recruiting

  • East Texas Cardiology PA

    Houston, Texas 77002
    United States

    Site Not Available

  • NextStage Clinical Research-Port Arthur-(02)

    Port Arthur, Texas 77642
    United States

    Active - Recruiting

  • Sherman Clinical Research

    Sherman, Texas 75092
    United States

    Active - Recruiting

  • Waco Cardiology Associates - NextStage Clinical Research

    Waco, Texas 76712
    United States

    Active - Recruiting

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