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JTT-861

Phase 2

Chronic Heart Failure | Small molecule | Cardiovascular |Icon Plc|Last Updated: Feb 9, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment314
FDA Designations
No designations recorded
Clinical trial landscape

JTT-861 · 1 trial · 1 indication

Phase 2 1
NCT06017609Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection FractionChronic Heart Failure
ACTIVE NOT_RECRUITING314 Analytics
PHASE2ACTIVE NOT_RECRUITING
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
Chronic Heart Failure
NCT06017609314
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Study Endpoints
Primary Endpoints
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
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

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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JTT-861 Dose 1EXPERIMENTALJTT-861 Capsules Dose 1 orally once daily for 12 weeks
JTT-861 Dose 2EXPERIMENTALJTT-861 Capsules Dose 2 orally once daily for 12 weeks
PlaceboEXPERIMENTALPlacebo Capsules orally once daily for 12 weeks
Interventions
NameTypeDescription
JTT-861 CapsulesDRUGActive drug capsules containing JTT-861
Placebo CapsulesDRUGPlacebo capsules matching in appearance to the active drug capsules
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Eligibility Criteria
Age Range30 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites75

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 Asso...

Countries:United StatesBulgariaCzechiaPolandRomaniaSpain
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06017609studyFirstPostDate: changed