HF-POLARIS: A research study to look at how well NNC0487-0111 works compared to placebo in people with heart failure and obesity

Prior treatment

• Myocardial infarction (MI), stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization
• Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
• Treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion.
• Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as: - requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD exacerbation within 12 months prior to screening.

Other illness

• HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree.
• Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).
  • CCI
  • CCI
• History of type 1 diabetes.

Lab values

• HbA1c >10% (86 mmol/mol) as measured by local or central laboratory at screening.
  • CCI
  • CCI

Other

• Coronary, carotid, or peripheral artery revascularization planned during the study period and known at screening (visit 1).

• Body Mass Index (BMI) ≥30 kg/m2 at screening.
• Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator.
  • CCI
  • CCI
  • For participants with T2D at screening: 5. Diagnosed with T2D ≥ 30 days before screening.
  • CCI