xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06017609</url>
    </required_header>
    <id_info>
      <org_study_id>AT861-G-22-002</org_study_id>
      <nct_id>NCT06017609</nct_id>
    </id_info>
    <brief_title>Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction</brief_title>
    <acronym>POWER-HF</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Akros Pharma Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ICON Clinical Research</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Akros Pharma Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861&#xD;
        administered once daily for 12 weeks in subjects with heart failure with reduced ejection&#xD;
        fraction (HFrEF) who are on a stable, guideline-directed medical therapy for heart failure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline to end of treatment (EOT) in left ventricular ejection fraction (LVEF) as assessed by two-dimensional echocardiography (2D-echo)</measure>
      <time_frame>12 Weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo</measure>
      <time_frame>12 Weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo</measure>
      <time_frame>12 Weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo</measure>
      <time_frame>12 Weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP)</measure>
      <time_frame>12 Weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline</measure>
      <time_frame>16 Weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of subjects with treatment-emergent adverse events</measure>
      <time_frame>Up to 16 Weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Trough plasma concentrations of JTT-861</measure>
      <time_frame>Weeks 4, 8 and 12</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Post-dose plasma concentrations of JTT-861</measure>
      <time_frame>Weeks 2, 4 and 8</time_frame>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Chronic Heart Failure</condition>
    <arm_group>
      <arm_group_label>JTT-861 Dose 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>JTT-861 Capsules Dose 1 orally once daily for 12 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>JTT-861 Dose 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>JTT-861 Capsules Dose 2 orally once daily for 12 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Placebo Capsules orally once daily for 12 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>JTT-861 Capsules</intervention_name>
      <description>Active drug capsules containing JTT-861</description>
      <arm_group_label>JTT-861 Dose 1</arm_group_label>
      <arm_group_label>JTT-861 Dose 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo Capsules</intervention_name>
      <description>Placebo capsules matching in appearance to the active drug capsules</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Has a clinical diagnosis of symptomatic heart failure (HF) ≥90 days prior to the&#xD;
               Screening Visit;&#xD;
  &#xD;
            -  Is in New York Heart Association (NYHA) functional class II or III at the Screening&#xD;
               Visit;&#xD;
  &#xD;
            -  Is on stable, guideline-directed therapy for HF, consistent with American Heart&#xD;
               Association (AHA), American College of Cardiology (ACC), Heart Failure Society of&#xD;
               America (HFSA) or European Society of Cardiology (ESC) guidelines for ≥4 weeks prior&#xD;
               to the Screening Visit (with at least half of maximal labeled dose of&#xD;
               renin-angiotensin-aldosterone system (RAAS) inhibitors and β-blockers, if tolerated);&#xD;
  &#xD;
            -  Has left ventricular ejection fraction (LVEF) ≤35% at the Screening Visit;&#xD;
  &#xD;
            -  Has a serum N-terminal pro b-type natriuretic peptide (NT-pro-BNP) level ≥600 pg/mL&#xD;
               (or ≥900 pg/mL if the subject has atrial fibrillation or atrial flutter) at the&#xD;
               Screening Visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a confirmed acute myocardial infarction (MI) (i.e., Type 1) or unstable angina&#xD;
               within 90 days prior to the Screening Visit;&#xD;
  &#xD;
            -  Has a history of coronary revascularization (percutaneous coronary intervention [PCI]&#xD;
               and/or coronary artery bypass graft [CABG]) or other cardiovascular surgery within 90&#xD;
               days prior to the Screening Visit or planned cardiovascular surgery during the study&#xD;
               through the Follow-up Visit);&#xD;
  &#xD;
            -  Has started cardiac resynchronization therapy (CRT) within 90 days prior to the&#xD;
               Screening Visit or has planned CRT during the study through the Follow-up Visit;&#xD;
  &#xD;
            -  Has clinically significant congenital heart disease, active myocarditis or&#xD;
               constrictive pericarditis;&#xD;
  &#xD;
            -  Has current acute decompensated HF requiring additional treatment with diuretics,&#xD;
               vasodilators and/or inotropic medications at the Screening Visit;&#xD;
  &#xD;
            -  Has clinically significant chronic renal insufficiency (i.e., estimated glomerular&#xD;
               filtration rate [eGFR] &lt;30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease&#xD;
               Epidemiology Collaboration [CKD-EPI] creatinine equation) at the Screening Visit.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kazuhiro Okamiya, M.S</last_name>
      <phone>609-919-9570</phone>
      <email>ClinicalTrials@akrospharma.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kala Patel, R.Ph., RAC</last_name>
      <phone>609-919-6131</phone>
      <email>ClinicalTrials@akrospharma.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>East Texas Cardiology PA</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77002</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>JTT-861</keyword>
    <keyword>Efficacy</keyword>
    <keyword>Safety</keyword>
    <keyword>Tolerability</keyword>
    <keyword>Chronic Heart Failure</keyword>
    <keyword>HFrEF</keyword>
    <keyword>Heart Failure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06017609
  org study id: AT861-G-22-002
  nct id: NCT06017609
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: 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
  measure: Change from baseline to EOT in left ventricular end-systolic volume (LVESV) index as assessed by 2D-echo
  time frame: 12 Weeks
  measure: Change from baseline to EOT in left ventricular end-diastolic volume (LVEDV) index as assessed by 2D-echo
  time frame: 12 Weeks
  measure: Change from baseline to EOT in left atrial volume (LAV) as assessed by 2D-echo
  time frame: 12 Weeks
  measure: Change from baseline to EOT in N-terminal pro b-type natriuretic peptide (NT-pro-BNP)
  time frame: 12 Weeks
  measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline
  time frame: 16 Weeks
  measure: Number of subjects with treatment-emergent adverse events
  time frame: Up to 16 Weeks
  measure: Trough plasma concentrations of JTT-861
  time frame: Weeks 4, 8 and 12
  measure: Post-dose plasma concentrations of JTT-861
  time frame: Weeks 2, 4 and 8
  arm group label: JTT-861 Dose 1
  arm group type: Experimental
  description: JTT-861 Capsules Dose 1 orally once daily for 12 weeks
  arm group label: JTT-861 Dose 2
  arm group type: Experimental
  description: JTT-861 Capsules Dose 2 orally once daily for 12 weeks
  arm group label: Placebo
  arm group type: Experimental
  description: Placebo Capsules orally once daily for 12 weeks
  intervention type: Drug
  intervention name: JTT-861 Capsules
  description: Active drug capsules containing JTT-861
  arm group label: JTT-861 Dose 1
  arm group label: JTT-861 Dose 2
  intervention type: Drug
  intervention name: Placebo Capsules
  description: Placebo capsules matching in appearance to the active drug capsules
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Kazuhiro Okamiya, M.S
  phone: 609-919-9570
  email: ClinicalTrials@akrospharma.com
  last name: Kala Patel, R.Ph., RAC
  phone: 609-919-6131
  email: ClinicalTrials@akrospharma.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: No