A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body Mass Index (BMI) greater than or equal to (>=) 30 kilograms per square metre (kg/m²) at screening.
Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator.
Disqualifiers
MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization.
HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree.
requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening.
Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).
Trial design
Design model
Parallel
Treatments tested in this trial
NNC0487-0111
DrugNNC0487-011 will be administered subcutaneously.
Placebo
DrugPlacebo will be administered subcutaneously.
Treatment groups
5,610 Participants
are divided into 2 treatment groupsGroup A: NNC0487-0111Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeksSecondary outcomes
1
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 weeks2
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 523
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 millilitre per minute per 1.73 square metre (mL/min/1.73 m^2)
Measured as mL/min/1.73 m\^2.
Time frame
From baseline (week 0) to week 784
Time to all-cause death
Measured in days.
Time frame
From baseline (week 0) to 165 weeksSponsors and contacts
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Source ClinicalTrials.gov