A Master Protocol for Semaglutide Effects on Cardiovascular and Obesity-related Outcomes in Peopl… (NCT07141914) | Clinical Trial Compass
CompletedNot Applicable
A Master Protocol for Semaglutide Effects on Cardiovascular and Obesity-related Outcomes in People With Overweight or Obesity in the Real World
United States285,327 participantsStarted 2025-08-29
Plain-language summary
This study aims to evaluate the association of once-weekly semaglutide with the risk of cardiovascular (CV) and other obesity-related clinical outcomes in three study populations (Heart failure (HF), clinical Atherosclerotic Cardiovascular Disease (ASCVD), primary prevention).
This is a retrospective cohort study which includes administrative medical and pharmacy claims linked with clinical and laboratory measurements for participants in the US during January 1, 2016 - December 31, 2024.
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
✓. Participants with overweight or obesity defined as at least one overweight/obesity indication of a specified body mass index (BMI) more than or equal to (≥) 27.0 kilogram per meter square (kg/m2) and undefined obesity indications, defined by diagnoses and laboratory values, during January 1, 2016 to December 31, 2024
✓. Participants with a record indicating the study population of interest during January 1, 2016 to December 31, 2024
✓. Smoking history
✓. Dyslipidaemia
✓. Hypertension
✓. Prediabetes
✓. Chronic kidney disease (CKD) or evidence of kidney function decline/kidney damage
✓. High-sensitivity C-reactive protein (hs-CRP) more than or equal to (≥) 2 milligram per litre (mg/L)
Exclusion criteria
✕. HF and Clinical ASCVD Populations: Diagnosis of end-stage HF
What they're measuring
1
Revised 5-Point Major Adverse Cardiovascular Events (MACE-5) (time-to-event)
Timeframe: Index date, earliest of revised MACE-5 and end of follow-up; up to 42 months
2
Revised 3-point Major Adverse Cardiovascular Events MACE-3 (time-to-event)
Timeframe: Index date, earliest of revised MACE-3 and end of follow-up; up to 42 months