Status:
COMPLETED
Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity in the Real World
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Overweight
Obesity
Eligibility:
All Genders
45+ years
Brief Summary
This is a retrospective database study which includes administrative medical and pharmacy claims linked with clinical and laboratory measurements for patients in the US, to evaluate the effectiveness ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Participants with overweight or obesity defined as at least one overweight/obesity indication of a specified body mass index (BMI) above or equal to (≥) 27.0 kilogram per meter square (kg/m\^2) and undefined obesity/overweight indications, defined by diagnoses and laboratory values
- Participants with established ASCVD defined as a diagnosis of MI, diagnosis of ischemic stroke, and/or evidence of peripheral arterial disease
- Participants who are above or equal to (≥) 45 years old by the end of data availability
- Participants who initiated semaglutide 2.4 mg on or after the eligibility date and June4, 2021 (semaglutide 2.4 mg users) or participants with no evidence of semaglutide 2.4 mg usage (non-users) during January 1, 2016 to December 31, 2023
- Participant with continuous insurance enrolment eligibility above or equal to (≥)12 months prior to the index date
- Participants with re-confirmed overweight/obesity indication during the baseline period
- Exclusion criteria:
- Participants with a diagnosis of chronic or acute pancreatitis
- Participants with a diagnosis of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- Participants with end-stage kidney disease (ESKD) including chronic or intermittent hemodialysis or peritoneal dialysis, kidney transplant, and/or record of estimate glomerular filtration rate less than (\<) 15 milliliter per minute per 1.73\*meter square (mL/min/1.73m\^2)
- Pregnancy in female participants
- Participants with evidence of diabetes including more or equal to (≥)2 diagnoses of type 1 diabetes or more or equal to ( ≥) 2 diagnoses of type 2 diabetes on distinct dates, use of a glucose-lowering agent, and/or glycated hemoglobin (HbA1c) laboratory result above or equal to 6.5 percent (%)
- Use of a glucagon-like peptide-1 (GLP-1) or GLP-1/gastric inhibitory polypeptide (GIP) receptor ago-nist approved for weight management (excluding semaglutide 2.4 mg)
- Participants with evidence of bariatric surgery
Exclusion
Key Trial Info
Start Date :
December 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 28 2025
Estimated Enrollment :
45456 Patients enrolled
Trial Details
Trial ID
NCT06874751
Start Date
December 6 2024
End Date
March 28 2025
Last Update
May 21 2025
Active Locations (1)
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1
Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States, 08536