Effect of semaglutide 2.4 mg once weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction.
Phase 3
Completed
- Conditions
- obesitasheartfailureobesity10019280
- Registration Number
- NL-OMON51952
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
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
Exclusion Criteria
• A self-reported change in body weight > 5 kg (11 lbs) within 90 days before
screening
irrespective of medical records
• Haemoglobin A1c (HbA1c) >= 6.5 % (48 mmol/mol) based on latest available value
from medical
records, no older than 3 months or if unavailable a local measurement at
screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints are change in KCCQ (clinical summary score) and change in<br /><br>body weight from baseline to end of treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints are change in C-Reactive Protein (CRP) and change in<br /><br>six-minute walking distance from baseline to end of treatment.<br /><br>Hierarchical composite of:<br /><br>- Time to all-cause death, number of heart failure events requiring<br /><br>hospitalisation or urgent heart failure visit,<br /><br>- time to first heart failure event requiring hospitalisation or urgent heart<br /><br>failure visit,<br /><br>- difference at least 15 in KCCQ clinical summary score change from baseline to<br /><br>52 weeks,<br /><br>- difference at least 10 in KCCQ clinical summary score change from baseline to<br /><br>52 weeks,<br /><br>- difference at least 5 in KCCQ clinical summary score change from baseline to<br /><br>52 weeks,<br /><br>- difference at least 30 metres in sixminute walking distance change from<br /><br>baseline to 52 weeks<br /><br>(assessed by the win ratio)</p><br>