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
- Conditions
- Type2 diabetes and obesity-related heart failure with preserved ejection fraction
- Registration Number
- JPRN-jRCT2061210014
- Lead Sponsor
- Kinoshita Kazunori
- 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
- Not specified
- Primary Outcome Measures
Name Time Method Multiple primary endpoints<br>-Change in KCCQ clinical summary<br>-score (no unit, range; 0-100) From baseline (week 0) to end of treatment (week 52)<br>-Change in body weight (%) From baseline (week 0) to end of treatment (week 52)
- Secondary Outcome Measures
Name Time Method