Research study to look at how well semaglutide works in people living with heart failure, obesity and type 2 diabetes.
- Conditions
- Health Condition 1: I00-I99- Diseases of the circulatory system
- Registration Number
- CTRI/2021/11/038164
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
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
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 1- Change in KCCQ clinical summary <br/ ><br>score <br/ ><br> <br/ ><br>2- Change in body weight <br/ ><br>The 6MWT must be performed in accordance with the manual provided by Novo NordiskTimepoint: 1) Time frame-From baseline (week 0) to end of <br/ ><br>treatment (week 52) <br/ ><br>Unit- Score (no unit, range; 0-100) <br/ ><br> <br/ ><br>2) Time frame: From baseline (week 0) to end of <br/ ><br>treatment (week 52) <br/ ><br>Unit: %
- Secondary Outcome Measures
Name Time Method Change in 6-minute walking distanceTimepoint: From baseline (week 0) to end of <br/ ><br>treatment (week 52);Change in C-Reactive ProteinTimepoint: From baseline (week -2) to end of treatment (week 52)