A Phase II Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)

Assess the safety and tolerability profile of multiple doses of IV administered JK07 versus placebo.

For more information, visit https://clinicaltrials.gov/study/NCT06369298

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042

• Participants with NYHA functional Class II-III for at least 8 weeks prior to screening AND:
  • Cohort 1 (LVEF ≤ 40%): A screening LVEF ≤ 40% in the absence of hemodynamically significant and/or severe valvular disease (other than mitral valve regurgitation and/or tricuspid regurgitation) on 2D-TTE, with at least one other documented LVEF measurement ≤ 40% within the last 52 weeks prior to screening determined by echocardiography, radionuclide ventriculogram, cardiac computed tomography (CT), or cardiac magnetic resonance imaging (CMR).
    • In participants with a screening LVEF ≥ 30% and ≤ 40%, elevated level of NT-proBNP (≥ 300 pg/mL).

    • Participants who have undergone coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or implantation of a cardiac resynchronization therapy (CRT) device must have a measurement of LVEF ≤ 40% at least 12 weeks after the intervention to be eligible for participation (Note: the echo used to confirm this criterion can be the same as the screening echo).

      OR

  • Cohort 2 (LVEF > 40% and ≤ 65%): A screening LVEF between 40% and 65% in the absence of hemodynamically significant and/or severe valvular disease on 2DTTE, with at least one other documented LVEF measurement between 40% and 65% and within 52 weeks prior to screening as confirmed by echocardiography, radionuclide ventriculogram, cardiac CT, or CMR, AND
    • Elevated level of NT-proBNP (≥ 600 pg/mL).
    • Documented evidence of paroxysmal (on ≥ 2 occasions ≥ 1 week apart), persistent or permanent atrial fibrillation/flutter by electrocardiogram, Holter, implantable device, or telemetry based event monitoring within the last 5 years
• Participants should be established on background optimal medical therapy for HF and be treated according to locally recognized guidelines with both drugs and devices, as appropriate.

Cardiac-Related Criteria

•  Uncontrolled hypertension (defined as systolic BP ≥ 180 mmHg, or based on the opinion of the Investigator) during the screening visit.
• Sustained systolic BP < 90 mmHg and/or diastolic BP < 50 mmHg on 2 consecutive (duplicate seated) readings at screening.
• Participants with poor echo windows that preclude accurate repeat assessments of LVEF.

Non-Cardiac Criteria

•  Any past participation in a study that has investigated the NRG-1 pathway (e.g., Neucardin, cimaglermin, JK07). 24.
• Pregnant or breastfeeding women 25.