obesitas hartfailure obesity
Conditions
Sponsors
Novo Nordisk
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female, age above or equal to 18 years at the time of signing informed consent. • Body mass index (BMI) >= 30.0 kg/m2 • New York Heart Association (NYHA) Class II-IV • Left ventricular ejection fraction (LVEF) >= 45% at screening • Diagnosed with T2D >= 90 days prior to the day of screening • HbA1c of
Exclusion criteria
Exclusion criteria: • A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are change in KCCQ (clinical summary score) and change in body weight from baseline to end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are change in C-Reactive Protein (CRP) and change in six-minute walking distance from baseline to endof treatment. Hierarchical composite of: - Time to all-cause death, number of heart failure events requiring hospitalisation or urgent heart failure visit, - time to first heart failure event requiring hospitalisation or urgent heart failure visit, - difference at least 15 in KCCQ clinical summary score change from baseline to 52 weeks, - difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks, - difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks, - difference at least 30 metres in sixminute walking distance change from baseline to 52 weeks (assessed by the win ratio). | — |
Countries
Netherlands
Outcome results
None listed