*HF-POLARIS

• Research type

  Research Study

• Full title

  Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).

• IRAS ID

  1013316

• Contact name

  Dept 2834

• Contact email

  clinicaltrials@novonordisk.com

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2025-523717-29

• Clinicaltrials.gov Identifier

  NCT07567001

• Research summary

  Heart failure is a condition where the heart isn’t able to pump blood as well as it should. People with this condition also have a higher risk of dying or worsening of the disease that require hospitalisation or urgent hospital visits. People with excess weight have a higher risk for developing heart failure, especially subtypes including heart failure with preserved or mildly reduced (lower) ejection fraction. The study medicine NNC0487-0111 is a medicine which may help people lower the risk of death or worsening of heart failure leading to hospitalization. The study will include 5610 people with heart failure and excess body weight. To be in the study, they must have heart failure with left ventricular ejection fraction of more than 40% and excess body weight. Ejection fraction is used to measure how much blood the heart can pump with each beat. People cannot take part in the study if they have had a heart attack, angina or worsening heart failure leading to hospitalisation within last 30 days of screening. Women can also not take part if they are pregnant, breastfeeding or planning to become pregnant during the study. This will be compared to placebo which has no effect on the body. Participants will be randomised in a 1:1 manner to the active drug or placebo.
  Participants will be asked to come for around 23 visits at the clinic with the study staff over a period of approximately 3 years. The participants will have physical examinations where the study staff measures standard health measurements. Height, weight, waist circumference and parameters in blood and urine will be measured. Eyes, heart, and body in general will also be checked. Participants will be asked to fill out quality of life and health-related questionnaires. Women who can get pregnant will have a blood test to check if they are pregnant and will need to use urine pregnancy tests at the clinic visit and at home every 4 weeks and have phone calls to report pregnancy test results

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  26/LO/0112

• Date of REC Opinion

  26 Feb 2026

• REC opinion

  Further Information Favourable Opinion