EUCTR2019-004452-11-DKActive, not recruitingPhase 1
Effect of semaglutide 2.4 mg once weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction - STEP-HFpEF
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 516
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Male or female, age above or equal to 18 years at the time of signing informed consent.
- •- Body mass index (BMI) equal to or above 30.0 kg/m^2
- •- New York Heart Association (NYHA) Class II-IV
- •- Left ventricular ejection fraction (LVEF) equal to or above 45 % at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 258
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 258
Exclusion Criteria
- •- A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •- Glycated haemoglobin A1c (HbA1c) equal to or above 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
Investigators
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