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

NCT06017609 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: AT861-G-22-002
• Study Type: interventional
• Target: 314
• Locations: 6 countries
• Sites: 75

Brief 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.

Conditions

Chronic Heart Failure

Keywords

JTT-861; Efficacy; Safety; Tolerability; Chronic Heart Failure; HFrEF; Heart Failure

Outcome Measures

Primary Outcomes (9)

• Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo)

  12 Weeks

• Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo

  12 Weeks

• Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo

  12 Weeks

• Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo

  12 Weeks

• Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values

  12 Weeks

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline

  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

• Number of subjects with treatment-emergent adverse events

  Up to 16 Weeks

• Trough plasma concentrations of JTT-861

  Weeks 4, 8 and 12

• Post-dose plasma concentrations of JTT-861

  Weeks 2, 4 and 8

Study Arms (3)

JTT-861 Dose 1

EXPERIMENTAL

JTT-861 Capsules Dose 1 orally once daily for 12 weeks

Drug: JTT-861 Capsules

JTT-861 Dose 2

EXPERIMENTAL

JTT-861 Capsules Dose 2 orally once daily for 12 weeks

Drug: JTT-861 Capsules

Placebo

EXPERIMENTAL

Placebo Capsules orally once daily for 12 weeks

Drug: Placebo Capsules

Interventions

JTT-861 Capsules DRUG

Active drug capsules containing JTT-861

JTT-861 Dose 1; JTT-861 Dose 2

Placebo Capsules DRUG

Placebo capsules matching in appearance to the active drug capsules

Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akros Pharma Inc.: lead
• ICON Clinical Research: collaborator

Study Sites (75)

Arensia Exploratory Medicine Inc.

Phoenix, Arizona, 85015, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

Indago Research & Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Med Research of Florida

Miami, Florida, 33186, United States

Location

Pharma Medical Innovation, Inc.

Miami Lakes, Florida, 33014, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Affinity Health

Park Ridge, Illinois, 60068, United States

Location

ASHA Clinical Research-Munster, LLC

Hammond, Indiana, 46324, United States

Location

Monroe Research, LLC

West Monroe, Louisiana, 71291, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Profound Research LLC

Farmington Hills, Michigan, 48334, United States

Location

NextStage Clinical Research - (Kansas City [01])

Kansas City, Missouri, 64114, United States

Location

Laurelton Heart Specialist P.C.

Rosedale, New York, 11422, United States

Location

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Onsite Clinical Solutions, LLC

Rock Hill, South Carolina, 29732, United States

Location

NextStage Clinical Research-Beaumont- (01)

Beaumont, Texas, 77702, United States

Location

Cypress Heart and Vascular Center

Cypress, Texas, 77429, United States

Location

NextStage Clinical Research-Port Arthur-(02)

Port Arthur, Texas, 77642, United States

Location

Sherman Clinical Research

Sherman, Texas, 75092, United States

Location

Waco Cardiology Associates - NextStage Clinical Research

Waco, Texas, 76712, United States

Location

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

Burgas, 8000, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Ivan Skenderov"

Gotse Delchev, 2900, Bulgaria

Location

Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD

Gotse Delchev, 2900, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Georgi Stranski, EAD

Pleven, 5803, Bulgaria

Location

Multiprofile Hospital For Active Treatment Heart and Brain EAD

Pleven, 5804, Bulgaria

Location

University Multiprofile Hospital For Active Treatment Saint Georgi EAD

Plovdiv, 4002, Bulgaria

Location

Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD

Sofia, 1415, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, 1527, Bulgaria

Location

Diagnostic Consultative Center Convex EOOD

Sofia, 1680, Bulgaria

Location

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

Sofia, 1750, Bulgaria

Location

MUDr. Libor Nechvatal s.r.o.

Brno, 602 00, Czechia

Location

Centrum pro zdraví, s.r.o.

Brno, 603 00, Czechia

Location

Vojenská nemocnice Brno

Brno, 615 00, Czechia

Location

Fakultní nemocnice Brno

Brno, 625 00, Czechia

Location

Edumed s.r.o.

Broumov, 550 01, Czechia

Location

Edumed s.r.o.

Hradec Králové, 500 02, Czechia

Location

Edumed s.r.o.

Jaroměř, 551 01, Czechia

Location

Edumed s.r.o.

Náchod, 547 01, Czechia

Location

Fakultní nemocnice Ostrava

Ostrava-Poruba, 708 52, Czechia

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

Location

American Heart of Poland S.A.

Chrzanów, 32-500, Poland

Location

American Heart of Poland S.A.

Dąbrowa Górnicza, 41-300, Poland

Location

Kardio Brynów Sp. z o.o.

Katowice, 40-555, Poland

Location

Centrum Rehabilitacji I Kardiologii Solutaris Prokopczuk Sp.j.

Kędzierzyn-Koźle, 47-200, Poland

Location

Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego

Lodz, 91-347, Poland

Location

Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20-090, Poland

Location

Trialmed CRS Piotrków Trybunalski

Piotrkow Trybunalski, 97-300, Poland

Location

NZOZ "Pro Cordis" Sopockie Centrum Badań Kardiologicznych Paweł Miękus

Sopot, 81-717, Poland

Location

American Heart of Poland S.A.

Tychy, 43-100, Poland

Location

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

Wroclaw, 53-114, Poland

Location

Thera Card S.R.L

Brasov, 500102, Romania

Location

Spitalul Clinic Judetean De Urgenta Brasov

Brasov, 500326, Romania

Location

Spitalul Clinic De Urgență Sf. Pantelimon București

Bucharest, 021659, Romania

Location

Spitalul Universitar de Urgență București

Bucharest, 050098, Romania

Location

Mat Cord Biomedica SRL

Buzău, 120133, Romania

Location

Angiocare S.R.L.

Cluj-Napoca, 400015, Romania

Location

Cardio Med SRL

Craiova, 200513, Romania

Location

Spitalul Clinic Județean de Urgență Craiova

Craiova, 200642, Romania

Location

Cardio Med SRL

Târgu Mureş, 540124, Romania

Location

CMI Dr. Podoleanu Cristian

Târgu Mureş, 540143, Romania

Location

Spitalul Clinic Municipal de Urgenţă Timişoara

Timișoara, 300024, Romania

Location

Spitalul Clinic Municipal de Urgenţă Timişoara

Timișoara, 300079, Romania

Location

Hospital Clínico Universitario de Santiago

A Coruña, 15706, Spain

Location

Hospital del Mar - Parc de Salut Mar

Barcelona, 08003, Spain

Location

Area Sanitaria De Ferrol - Hospital Arquitecto Marcide

Ferrol, 15405, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, 28222, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: December 20, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (12); ES (12); BU (11); CZ (9); PL (11); US (20)