Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 24, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT06017609). This is a study registration, not published results. Lead sponsor: Akros Pharma Inc.. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 314 participants (ACTUAL). Conditions: Chronic Heart Failure. Interventions: DRUG: JTT-861 Capsules; DRUG: Placebo Capsules. Primary outcome measures: 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; 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. 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.