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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

28 Apr 2026 → ongoing

Decision date (initial)

2026-05-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2025-523717-29-00

WHO UTN

U1111-1328-2701

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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.

Secondary objectives 2

1. To demonstrate the effects of NNC0487‑0111 once weekly versus placebo, both added to SoC, in participants with HFpEF or HFmrEF, and obesity regards to: Occurrence of CV and HF outcomes and mortality; Physical function and symptoms, Kidney function, Hospitalisation
2. CCI

Conditions and MedDRA coding

HFpEF or HFmrEF and obesity

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Body Mass Index (BMI) ≥30 kg/m2 at screening.
2. 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.
3. CCI
4. CCI
5. For participants with T2D at screening: 5. Diagnosed with T2D ≥ 30 days before screening.
6. CCI

Exclusion criteria 13

1. 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
2. CCI
3. 3. Coronary, carotid, or peripheral artery revascularization planned during the study period and known at screening (visit 1).
4. 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. 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. 6. Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).
7. CCI
8. CCI
9. 9. History of type 1 diabetes.
10. 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. 11. Treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion.
12. 12. HbA1c >10% (86 mmol/mol) as measured by local or central laboratory at screening.
13. CCI

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to first occurrence of a composite HF endpoint consisting of: CV death, HF hospitalisation or urgent HF visit

Secondary endpoints 33

1. Time to first occurrence of a composite HF and MACE endpoint consisting of: CV death, HF hospitalisation or urgent HF visit, Nonfatal MI, Nonfatal stroke
2. Change in KCCQ-CSS for participants with baseline KCCQ‑CSS score <80 points
3. Change in eGFR (creatinine and cystatin C‑based CKD‑EPI 2021) for participants with baseline eGFR<60 mL/min/1.73 m2
4. Time to all-cause death
5. CCI
6. CCI
7. CCI
8. CCI
9. CCI
10. CCI
11. CCI
12. CCI
13. CCI
14. CCI
15. CCI
16. CCI
17. CCI
18. CCI
19. CCI
20. CCI
21. CCI
22. CCI
23. CCI
24. CCI
25. CCI
26. CCI
27. CCI
28. CCI
29. CCI
30. CCI
31. CCI
32. CCI
33. CCI

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 9

Locations

10 EU/EEA countries · 269 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 129 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications