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

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

Phase

2

Condition

Congestive Heart Failure

Chest Pain

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

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

    Burgas 732770, 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 EOOD

    Gotse Delchev 731108, 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 Georgi Stranski, EAD

    Pleven 728203, 5803
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital For Active Treatment Saint Georgi EAD

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital For Active Treatment Saint Georgi EAD

    Plovdiv 728193, 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

  • Medical Center Hera EOOD

    Sofia 727011, 1510
    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

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

    Stara Zagora, 6003
    Bulgaria

    Site Not Available

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    Brno, 625 00
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    Czech Republic

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    Skierniewice, 96-100
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  • NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus

    Sopot, 81-717
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    Sopot 3085151, 81-717
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  • 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu

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  • Spitalul Clinic Judetean De Urgenta Brasov

    Brasov, 500326
    Romania

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    Brasov, 500102
    Romania

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  • Spitalul Clinic Judetean De Urgenta Brasov

    Brasov 683844, 500326
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  • Thera Card S.R.L

    Brasov 683844, 500102
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  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

    Brașov, 500283
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  • Spitalul Clinic De Urgență Sf. Pantelimon București

    Bucharest, 021659
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    Bucharest, 050098
    Romania

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    Bucharest 683506, 021659
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    Bucharest 683506, 050098
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    București, 021659
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    București, 050098
    Romania

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    Buzău, 120133
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    Cluj-Napoca 681290, 400015
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    Craiova, 200513
    Romania

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    Craiova, 200642
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    Craiova 680332, 200513
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    Craiova 680332, 200642
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    Timișoara, 300079
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    Timișoara 665087, 300079
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    Târgu Mureş, 540143
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    Târgu Mureş 665004, 540143
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    Târgu Mureș, 540143
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    Târgu Mureș, 540124
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  • Hospital Clínico Universitario de Santiago

    A Coruña, 15706
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    A Coruña 3119841, 15706
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    Barcelona, 08003
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    Barcelona 3128760, 08003
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    Ferrol, 15405
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    Madrid, 28007
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    Madrid, 28040
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    Madrid, 28046
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    Madrid, 28222
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    Madrid 3117735, 28007
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    Valencia, 46010
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    Valencia, 46026
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    Valencia 2509954, 46010
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    Valencia 2509954, 46026
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  • Arensia Exploratory Medicine Inc.

    Phoenix, Arizona 85015
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    Phoenix 5308655, Arizona 5551752 85015
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    Crystal River, Florida 34429
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    Hialeah, Florida 33012
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    Miami, Florida 33186
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    Miami Lakes, Florida 33014
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    Tamarac, Florida 33321
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    Eatonton, Georgia 31024
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    Park Ridge, Illinois 60068
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    Park Ridge 4905367, Illinois 4896861 60068
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    Hammond, Indiana 46324
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    Detroit, Michigan 48202
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    Kew Gardens, New York 11415
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    Rosedale, New York 11422
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    Rosedale 5134395, New York 5128638 11422
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    Greensboro, North Carolina 27405
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    Beaumont, Texas 77702
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    Coppell, Texas 75019
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    Cypress, Texas 77429
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    Sherman, Texas 75092
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    Waco, Texas 76712
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    Beaumont 4672989, Texas 4736286 77702
    United States

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    Cypress 4684724, Texas 4736286 77429
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    Port Arthur 4720039, Texas 4736286 77642
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    Sherman 4728328, Texas 4736286 75092
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    Waco 4739526, Texas 4736286 76712
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