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Clinical Trials in the EU / 2025-523717-29-00
Authorised, recruiting Phase III

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).

2025-523717-29-00 · tracked via the Priya Life Science EU tracker
Sponsor type
Pharmaceutical company
Therapeutic area
Cardiovascular Diseases
Decision date
17/04/2026
Enrollment target
1992
Sites
Denmark, Greece, Bulgaria, Italy, Netherlands, Spain, Poland, Czechia, Germany, France

Condition studied

HFpEF or HFmrEF and obesity

Investigational medicinal product(s)

NNC0487-0111 B 10143NNC0487-0111 B 10146NNC0487-0111 B 10141Placebo (NNC0487-0111)NNC0487-0111 B 10144NNC0487-0111 B 10145NNC0487-0111 B 10142

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

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, Change in KCCQ-CSS for participants with baseline KCCQ‑CSS score <80 points, Change in eGFR (creatinine and cystatin C‑based CKD‑EPI 2021) for participants with baseline eGFR<60 mL/min/1.73 m2, Time to all-cause death, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523717-29-00 on CTIS ↗ ← All trials in the EU