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

Sponsor

Akros Pharma Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06017609

Collaborator

ICON Clinical Research (Industry)

300

Enrollment

Location

Arms

21.1

Anticipated Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Drug: JTT-861 Capsules Drug: Placebo Capsules	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 28, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JTT-861 Dose 1 JTT-861 Capsules Dose 1 orally once daily for 12 weeks	Drug: JTT-861 Capsules Active drug capsules containing JTT-861
Experimental: JTT-861 Dose 2 JTT-861 Capsules Dose 2 orally once daily for 12 weeks	Drug: JTT-861 Capsules Active drug capsules containing JTT-861
Experimental: Placebo Placebo Capsules orally once daily for 12 weeks	Drug: Placebo Capsules Placebo capsules matching in appearance to the active drug capsules

Arm

Intervention/Treatment

Experimental: JTT-861 Dose 1

JTT-861 Capsules Dose 1 orally once daily for 12 weeks

Drug: JTT-861 Capsules

Active drug capsules containing JTT-861

Experimental: JTT-861 Dose 2

JTT-861 Capsules Dose 2 orally once daily for 12 weeks

Drug: JTT-861 Capsules

Active drug capsules containing JTT-861

Experimental: Placebo

Placebo Capsules orally once daily for 12 weeks

Drug: Placebo Capsules

Placebo capsules matching in appearance to the active drug capsules

Outcome Measures

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) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 Association (AHA), American College of Cardiology (ACC), Heart Failure Society of America (HFSA) or European Society of Cardiology (ESC) guidelines for ≥4 weeks prior to the Screening Visit (with at least half of maximal labeled dose of renin-angiotensin-aldosterone system (RAAS) inhibitors and β-blockers, if tolerated);
Has left ventricular ejection fraction (LVEF) ≤35% at the Screening Visit;
Has a serum N-terminal pro b-type natriuretic peptide (NT-pro-BNP) level ≥600 pg/mL (or ≥900 pg/mL if the subject has atrial fibrillation or atrial flutter) at the Screening Visit.

Exclusion Criteria:

Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable angina within 90 days prior to the Screening Visit;
Has a history of coronary revascularization (percutaneous coronary intervention [PCI] and/or coronary artery bypass graft [CABG]) or other cardiovascular surgery within 90 days prior to the Screening Visit or planned cardiovascular surgery during the study through the Follow-up Visit);
Has started cardiac resynchronization therapy (CRT) within 90 days prior to the Screening Visit or has planned CRT during the study through the Follow-up Visit;
Has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis;
Has current acute decompensated HF requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the Screening Visit;
Has clinically significant chronic renal insufficiency (i.e., estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation) at the Screening Visit.