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

May 21, 2026 updated by: Akros Pharma Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

314

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Ambulatory for Specialized Outpatient Medical Care in Cardiology Individual Practice- Dr. Elena Dotcheva EOOD
      • Gotse Delchev, Bulgaria, 2900
        • Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD
      • Gotse Delchev, Bulgaria, 2900
        • Multiprofile Hospital for Active Treatment "Ivan Skenderov"
      • Pleven, Bulgaria, 5804
        • Multiprofile Hospital For Active Treatment Heart and Brain EAD
      • Pleven, Bulgaria, 5803
        • University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital For Active Treatment Saint Georgi EAD
      • Sofia, Bulgaria, 1510
        • Medical Center Hera EOOD
      • Sofia, Bulgaria, 1415
        • Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
      • Sofia, Bulgaria, 1527
        • Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
      • Sofia, Bulgaria, 1680
        • Diagnostic Consultative Center Convex EOOD
      • Sofia, Bulgaria, 1750
        • University Multiprofile Hospital for Active Treatment. Sv Anna - Sofia AD
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno
      • Brno, Czechia, 602 00
        • MUDr. Libor Nechvatal s.r.o.
      • Brno, Czechia, 603 00
        • Centrum pro zdraví, s.r.o.
      • Brno, Czechia, 615 00
        • Vojenská nemocnice Brno
      • Broumov, Czechia, 550 01
        • Edumed s.r.o.
      • Hradec Králové, Czechia, 500 02
        • Edumed s.r.o.
      • Jaroměř, Czechia, 551 01
        • Edumed s.r.o.
      • Náchod, Czechia, 547 01
        • Edumed s.r.o.
      • Ostrava-Poruba, Czechia, 708 52
        • Fakultni nemocnice Ostrava
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Chrzanów, Poland, 32-500
        • American Heart of Poland S.A.
      • Dąbrowa Górnicza, Poland, 41-300
        • American Heart of Poland S.A.
      • Katowice, Poland, 40-555
        • Kardio Brynów Sp. z o.o.
      • Kędzierzyn-Koźle, Poland, 47-200
        • Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp.j.
      • Lodz, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
      • Lublin, Poland, 20-090
        • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
      • Piotrkow Trybunalski, Poland, 97-300
        • Trialmed CRS Piotrków Trybunalski
      • Sopot, Poland, 81-717
        • NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus
      • Tychy, Poland, 43-100
        • American Heart of Poland S.A.
      • Wroclaw, Poland, 53-114
        • 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu
  • Romania
      • Brasov, Romania, 500326
        • Spitalul Clinic Judetean De Urgenta Brasov
      • Brasov, Romania, 500102
        • Thera Card S.R.L
      • Bucharest, Romania, 050098
        • Spitalul Universitar de Urgenta Bucuresti
      • Bucharest, Romania, 021659
        • Spitalul Clinic De Urgență Sf. Pantelimon București
      • Buzău, Romania, 120133
        • Mat Cord Biomedica SRL
      • Cluj-Napoca, Romania, 400015
        • Angiocare S.R.L.
      • Craiova, Romania, 200642
        • Spitalul Clinic Judetean de Urgenta Craiova
      • Craiova, Romania, 200513
        • Cardio Med SRL
      • Timișoara, Romania, 300079
        • Spitalul Clinic Municipal de Urgenta Timisoara
      • Timișoara, Romania, 300024
        • Spitalul Clinic Municipal de Urgenta Timisoara
      • Târgu Mureş, Romania, 540124
        • Cardio Med SRL
      • Târgu Mureş, Romania, 540143
        • CMI Dr. Podoleanu Cristian
  • Spain
      • A Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago
      • Barcelona, Spain, 08003
        • Hospital del Mar - Parc de Salut Mar
      • Ferrol, Spain, 15405
        • Area Sanitaria De Ferrol - Hospital Arquitecto Marcide
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de La Arrixaca
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Arensia Exploratory Medicine Inc.
    • Florida
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc.
      • Miami, Florida, United States, 33186
        • Med Research of Florida
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research
      • Miami Lakes, Florida, United States, 33014
        • Pharma Medical Innovation, Inc.
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Affinity Health
    • Indiana
      • Hammond, Indiana, United States, 46324
        • ASHA Clinical Research-Munster, LLC
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
        • Monroe Research, LLC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Farmington Hills, Michigan, United States, 48334
        • Profound Research LLC
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • NextStage Clinical Research - (Kansas City [01])
    • New York
      • Rosedale, New York, United States, 11422
        • Laurelton Heart Specialist P.C.
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Capital Area Research, LLC
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • OnSite Clinical Solutions, LLC
    • Texas
      • Beaumont, Texas, United States, 77702
        • NextStage Clinical Research-Beaumont- (01)
      • Cypress, Texas, United States, 77429
        • Cypress Heart and Vascular Center
      • Port Arthur, Texas, United States, 77642
        • NextStage Clinical Research-Port Arthur-(02)
      • Sherman, Texas, United States, 75092
        • Sherman Clinical Research
      • Waco, Texas, United States, 76712
        • Waco Cardiology Associates - NextStage Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JTT-861 Dose 1
JTT-861 Capsules Dose 1 orally once daily for 12 weeks
Drug: JTT-861 Capsules
Active drug capsules containing JTT-861
Experimental: JTT-861 Dose 2
JTT-861 Capsules Dose 2 orally once daily for 12 weeks
Drug: JTT-861 Capsules
Active drug capsules containing JTT-861
Experimental: Placebo
Placebo Capsules orally once daily for 12 weeks
Drug: Placebo Capsules
Placebo capsules matching in appearance to the active drug capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Weeks
Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo
Time Frame: 12 Weeks
12 Weeks
Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo
Time Frame: 12 Weeks
12 Weeks
Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo
Time Frame: 12 Weeks
12 Weeks
Number of subjects with treatment-emergent adverse events
Time Frame: Up to 16 Weeks
Up to 16 Weeks
Trough plasma concentrations of JTT-861
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12
Post-dose plasma concentrations of JTT-861
Time Frame: Weeks 2, 4 and 8
Weeks 2, 4 and 8
Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values
Time Frame: 12 Weeks
12 Weeks
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline
Time Frame: 16 Weeks
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
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akros Pharma Inc.

Collaborators

ICON Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Actual)

May 18, 2026

Study Completion (Actual)

May 18, 2026

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT861-G-22-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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