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Recruiting Phase 3 2025-523717-29-00

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).

Phase 3 – large-scale trial before approval
Conditions: HFpEF or HFmrEF and obesity

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
Trial status: Authorised 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 Time to first occurrence of a composite HF endpoint consisting of: CV death, HF hospitalisation or urgent HF visit
Description
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
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 702 participants
Interventions
NNC0487-0111 B 10142
Drug
Placebo (NNC0487-0111)
Drug
NNC0487-0111 B 10143
Drug
NNC0487-0111 B 10146
Drug
NNC0487-0111 B 10144
Drug
NNC0487-0111 B 10145
Drug
NNC0487-0111 B 10141
Drug
Locations 5
Czech Republic (1)
France (1)
Germany (1)
Greece (1)
Netherlands (1)
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.04.2026
Registry ID
2025-523717-29-00
Source
euclinicaltrials.eu
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