NNC0487-0111
DrugNNC0487-011 will be administered subcutaneously.
NCT Number: NCT07567001
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
CEMEDIC, CABA, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For participants with Type 2 Diabetes (T2D) at screening:
Exclusion criteria
Glycaemia-related:
NNC0487-011 will be administered subcutaneously.
Placebo (matched to NNC0487-011) will be administered subcutaneously.
Time frame: From baseline (week 0) to 165 weeks
Measured in days.
Time frame: From baseline (week 0) to 165 weeks
Measured in days.
Time frame: From baseline (week 0) to 165 weeks
Measured in days.
Time frame: From baseline (week 0) to week 52
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.
Time frame: From baseline (week 0) to week 78
Measured as mL/min/1.73 m^2.
Time frame: From baseline (week 0) to 165 weeks
Measured in days.
Contact information is provided by the study sponsor or research team.
Novo Nordisk A/S
Industry
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
Acronym: HF-POLARIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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