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

Chronic Heart Failure Clinical Trial

— POWER-HF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017609
• Other study ID #: AT861-G-22-002
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Akros Pharma Inc.
• Contact: Takanori Nemoto, M.S.
• Phone: 609-919-9570
• Email: ClinicalTrials[@]akrospharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• JTT-861 Capsules
Active drug capsules containing JTT-861
• Placebo Capsules
Placebo capsules matching in appearance to the active drug capsules

Locations

Country	Name	City	State
United States	Cambridge Medical Trials	Alexandria	Louisiana
United States	Capital Area Research, LLC	Camp Hill	Pennsylvania
United States	Prime Revival Research Institute, LLC	Coppell	Texas
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	Cypress Heart and Vascular Center	Cypress	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Accel Research Site Network - Cardiology Care Clinic	Eatonton	Georgia
United States	Medication Management, LLC	Greensboro	North Carolina
United States	ASHA Clinical Research-Munster, LLC	Hammond	Indiana
United States	Indago Research & Health Center, Inc.	Hialeah	Florida
United States	East Texas Cardiology PA	Houston	Texas
United States	Marian David, MD, PC	Kew Gardens	New York
United States	Pharma Medical Innovation, Inc.	Miami Lakes	Florida
United States	Affinity Health	Park Ridge	Illinois
United States	Onsite Clinical Solutions, LLC	Rock Hill	South Carolina
United States	Laurelton Heart Specialist P.C.	Rosedale	New York
United States	Sherman Clinical Research	Sherman	Texas
United States	Waco Cardiology Associates - NextStage Clinical Research	Waco	Texas
United States	Monroe Research, LLC	West Monroe	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Akros Pharma Inc.	ICON Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo)		12 Weeks
Primary	Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo		12 Weeks
Primary	Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo		12 Weeks
Primary	Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo		12 Weeks
Primary	Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP) values		12 Weeks
Primary	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline	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	16 Weeks
Primary	Number of subjects with treatment-emergent adverse events		Up to 16 Weeks
Primary	Trough plasma concentrations of JTT-861		Weeks 4, 8 and 12
Primary	Post-dose plasma concentrations of JTT-861		Weeks 2, 4 and 8