Trial · Interventional
RecruitingPhase 3Registry dataA Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
Short name HF-POLARIS
Overview
- Status
- Recruiting
- Phase
- Phase 3
- Enrollment
- 5,610 participants (estimated)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Quadruple masking
- Countries
27 countries
United States, Argentina, Australia, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
- Start
- 11 May 2026
- Primary completion
- 23 Jul 2029 (estimated)
- Completion
- 15 Aug 2029 (estimated)
- First posted
- 5 May 2026
- Last update posted
- 18 Aug 2026
- Conditions
- Obesity · Heart Failure
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.
Interventions
- NNC0487-0111Drug
- PlaceboDrug
Arms2
Experimental
NNC0487-0111
Participants will receive NNC0487-0111 subcutaneously (s.c.) in a dose escalating manner once weekly.
Placebo comparator
Placebo
Participants will receive placebo matched to NNC0487-011 s.c. once weekly.
Primary outcomes2
Outcomes the sponsor listed as primary.
Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death
Time frame · From baseline (week 0) to 165 weeks
Registry description
Measured in days.
Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit
Time frame · From baseline (week 0) to 165 weeks
Registry description
Measured in days.
Secondary outcomes(4)
Time to first occurrence of a composite HF and Major Adverse Cardiovascular Events (MACE) end-point consisting of: CV death, HF hospitalisation or urgent HF visit, Nonfatal Myocardial Infraction (MI), Nonfatal stroke
Time frame · From baseline (week 0) to 165 weeks
Registry description
Measured in days.
Change in Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) for participants with baseline KCCQ-CSS score less than (<) 80 points
Time frame · From baseline (week 0) to week 52
Registry description
Measured as score on scale. KCCQ measures Health-Related Quality of Life (HRQOL). Score ranges from 0 to 100, with 0 as the lowest score and 100 as the highest score. Higher scores indicate better health status, fewer symptoms and greater disease-specific HRQoL.
Change in estimated Glomerular Filtration Rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021) for participants with baseline eGFR< 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2)
Time frame · From baseline (week 0) to week 78
Registry description
Measured as mL/min/1.73 m\^2.
Time to all-cause death
Time frame · From baseline (week 0) to 165 weeks
Registry description
Measured in days.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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