Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction, and type 2 diabetes (STEP HFpEF DM)
- Conditions
- Type2 diabetes and obesity-related heart failure with preserved ejection fraction
- Registration Number
- jRCT2061210014
- Lead Sponsor
- Novo Nordisk Pharma Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 610
-Male or female, age above or equal to 20 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 <= 10.0% as measured at the screening visit
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Change in KCCQ clinical summary score From baseline (week 0) to end of treatment (week 52) no unit, range; 0-100
Change in body weight From baseline (week 0) to end of treatment (week 52) %
- Secondary Outcome Measures
Name Time Method