Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction - Trial NCT06017609
Access comprehensive clinical trial information for NCT06017609 through Pure Global AI's free database. This Phase 2 trial is sponsored by Akros Pharma Inc. and is currently Recruiting. The study focuses on Chronic Heart Failure. Target enrollment is 300 participants.
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Study Focus
Sponsor & Location
Akros Pharma Inc.
Timeline & Enrollment
Phase 2
Aug 28, 2023
Jun 01, 2025
Primary Outcome
Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo),Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo,Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo,Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo,Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP),Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline,Number of subjects with treatment-emergent adverse events,Trough plasma concentrations of JTT-861,Post-dose plasma concentrations of JTT-861
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06017609
Non-Device Trial