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JTT-861

Phase 2

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

Target and mechanism

Molecular targetPDHK
ModalitySmall molecule

Also known as JTT-861 Capsules

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 FailureUnlock trial analytics

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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Frequently asked questions about JTT-861

What is JTT-861 used for?

JTT-861 is an investigational small molecule being developed for chronic heart failure, specifically heart failure with reduced ejection fraction. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does JTT-861 target?

JTT-861 targets PDHK, which stands for pyruvate dehydrogenase kinase. By inhibiting PDHK, the drug aims to modulate cardiac energy metabolism, which is relevant to its potential therapeutic effect in chronic heart failure.

Who is developing JTT-861?

JTT-861 is being developed by Icon Plc, a company publicly traded under the ticker symbol ICLR. The drug is currently in Phase 2 clinical trials for chronic heart failure.

What phase is JTT-861 in?

JTT-861 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies and is still undergoing clinical trials to evaluate its efficacy and safety.

What clinical trials is JTT-861 in?

JTT-861 is being studied in a Phase 2 clinical trial with the identifier NCT06017609. This trial is evaluating the efficacy, safety, and tolerability of JTT-861 in subjects with heart failure with reduced ejection fraction. The trial is active but not recruiting participants.

Is JTT-861 the same as JTT-861 Capsules?

Yes, JTT-861 is also known as JTT-861 Capsules. The drug is administered in capsule form, and both names refer to the same investigational medication being developed for chronic heart failure.