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HF-POLARIS: A research study to look at how well NNC0487-0111 works compared to placebo in people with heart failure and obesity
EU CTIS ID: 2025-523717-29-00
What this study is testing
To demonstrate that NNC0487-0111 once weekly versus placebo, both added to SoC, reduces the risk of a composite outcome including CV death, HF hospitalisation or urgent HF visit in participants with HFpEF or HFmrEF, and obesity.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Body Mass Index (BMI) ≥30 kg/m2 at screening.
- 2. 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
You likely can't join if
- 1. 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
- 10. 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.
- 11. Treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion.
- 12. HbA1c >10% (86 mmol/mol) as measured by local or central laboratory at screening.
- CCI
- CCI
See the full eligibility criteria
- 1. Body Mass Index (BMI) ≥30 kg/m2 at screening.
- 2. 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
- 1. 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
- 10. 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.
- 11. Treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion.
- 12. HbA1c >10% (86 mmol/mol) as measured by local or central laboratory at screening.
- CCI
- CCI
- 3. Coronary, carotid, or peripheral artery revascularization planned during the study period and known at screening (visit 1).
- 4. 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.
- 5. 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.
- 6. Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).
- CCI
- CCI
- 9. History of type 1 diabetes.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Israel
- Malaysia
- India
- Turkey
- Canada
- United States
- Mexico
- Argentina
- Brazil
- South Africa
- Taiwan
- Australia
- China
- Korea, Republic of
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Israel; Malaysia; India; Turkey; Canada and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.