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NCT06017609

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

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of JTT-861 Administered for 12 Weeks in Subjects With Heart Failure With Reduced Ejection Fraction
Akros Pharma Inc.·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Chronic Heart Failure
Drug/Device/Intervention
JTT-861 Capsules
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Akros Pharma Inc.
Location
Houston, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Aug 28, 2023
End date
Jun 01, 2025
Enrollment
300 participants
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
Heart failureHeart failure, unspecifiedCongestive heart failureHypertensive heart disease with (congestive) heart failureHypertensive heart disease without (congestive) heart failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06017609
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.