Status:
COMPLETED
Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of sem...
Eligibility Criteria
Inclusion
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) greater than or equal to 30.0 kg/m\^2
- New York Heart Association (NYHA) Class II-IV
- Left ventricular ejection fraction (LVEF) greater than or equal to 45% at screening
- Diagnosed with T2D greater than or equal to 90 days prior to the day of screening
- HbA1c of below or equal to 10.0% as measured at the screening visit
Exclusion
- A self-reported change in body weight greater than 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.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2023
Estimated Enrollment :
617 Patients enrolled
Trial Details
Trial ID
NCT04916470
Start Date
June 15 2021
End Date
October 11 2023
Last Update
November 26 2025
Active Locations (180)
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1
Eastern Shore Rsrch Inst, LLC
Fairhope, Alabama, United States, 36532
2
Mobile Heart Specialists
Mobile, Alabama, United States, 36608
3
National Heart Institute Cal
Beverly Hills, California, United States, 90211
4
John Muir Physicians Network
Concord, California, United States, 94520