search
Back to results

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

Primary Purpose

Chronic Heart Failure

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JTT-861 Capsules
Placebo Capsules
Sponsored by
Akros Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring JTT-861, Efficacy, Safety, Tolerability, Chronic Heart Failure, HFrEF, Heart Failure

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • East Texas Cardiology PARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

JTT-861 Dose 1

JTT-861 Dose 2

Placebo

Arm Description

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

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

Placebo Capsules orally once daily for 12 weeks

Outcomes

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)
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

Secondary Outcome Measures

Full Information

First Posted
August 24, 2023
Last Updated
August 24, 2023
Sponsor
Akros Pharma Inc.
Collaborators
ICON Clinical Research
search

1. Study Identification

Unique Protocol Identification Number
NCT06017609
Brief Title
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akros Pharma Inc.
Collaborators
ICON Clinical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
JTT-861, Efficacy, Safety, Tolerability, Chronic Heart Failure, HFrEF, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JTT-861 Dose 1
Arm Type
Experimental
Arm Description
JTT-861 Capsules Dose 1 orally once daily for 12 weeks
Arm Title
JTT-861 Dose 2
Arm Type
Experimental
Arm Description
JTT-861 Capsules Dose 2 orally once daily for 12 weeks
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo Capsules orally once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
JTT-861 Capsules
Intervention Description
Active drug capsules containing JTT-861
Intervention Type
Drug
Intervention Name(s)
Placebo Capsules
Intervention Description
Placebo capsules matching in appearance to the active drug capsules
Primary Outcome Measure Information:
Title
Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo)
Time Frame
12 Weeks
Title
Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo
Time Frame
12 Weeks
Title
Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo
Time Frame
12 Weeks
Title
Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo
Time Frame
12 Weeks
Title
Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
Time Frame
12 Weeks
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline
Time Frame
16 Weeks
Title
Number of subjects with treatment-emergent adverse events
Time Frame
Up to 16 Weeks
Title
Trough plasma concentrations of JTT-861
Time Frame
Weeks 4, 8 and 12
Title
Post-dose plasma concentrations of JTT-861
Time Frame
Weeks 2, 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kazuhiro Okamiya, M.S
Phone
609-919-9570
Email
ClinicalTrials@akrospharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kala Patel, R.Ph., RAC
Phone
609-919-6131
Email
ClinicalTrials@akrospharma.com
Facility Information:
Facility Name
East Texas Cardiology PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs