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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,610
NNC0487-011 will be administered subcutaneously.
Placebo (matched to NNC0487-011) will be administered subcutaneously.
Advanced Cardiovascular, LLC
Alexander City, Alabama, United States
RECRUITINGUniv of Alabama Birmingham
Birmingham, Alabama, United States
NOT_YET_RECRUITINGEastern Shore Rsrch Inst, LLC
Fairhope, Alabama, United States
RECRUITINGMobile Heart USA Health Cardiology Clinic
Mobile, Alabama, United States
Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death
Measured in days.
Time frame: From baseline (week 0) to 165 weeks
Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit
Measured in days.
Time frame: From baseline (week 0) to 165 weeks
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
Measured in days.
Time frame: From baseline (week 0) to 165 weeks
Change in Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) for participants with baseline KCCQ-CSS score less than (<) 80 points
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 52
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)
Measured as mL/min/1.73 m\^2.
Time frame: From baseline (week 0) to week 78
Time to all-cause death
Measured in days.
Time frame: From baseline (week 0) to 165 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
RECRUITINGSun City Clinical Research
Glendale, Arizona, United States
RECRUITINGHonor Health
Phoenix, Arizona, United States
NOT_YET_RECRUITINGArizona Research Center
Phoenix, Arizona, United States
NOT_YET_RECRUITINGArkansas Health Group
Little Rock, Arkansas, United States
NOT_YET_RECRUITINGInvivoCure -2
Alhambra, California, United States
RECRUITING...and 828 more locations