Status:
ENROLLING_BY_INVITATION
A Master Protocol for Semaglutide Effects on Cardiovascular and Obesity-related 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 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), ...
Eligibility Criteria
Inclusion
- 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
- 1\. HF: Diagnosis of HF 2. Clinical ASCVD: Diagnosis or procedure codes indicating:Coronary artery disease (CAD) including acute coronary syndrome (ACS; i.e., myocardial infarction \[MI\] or unstable angina), stable angina, coronary or other arterial revascularization or intervention, ischemic stroke, transient ischemic attack (TIA), carotid or other arterial stenosis, peripheral arterial disease (PAD) including aortic aneurysm 3. Primary Prevention: Patients at risk for developing ASCVD defined as the presence of more than or equal to (≥) 3 of the following risk factors
- 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)
- 3\. Participants who are more than or equal to (≥) 45 years old by December 31, 2024
- 4\. Participants will be divided into the following groups: those who initiate semaglutide on or after the eligibility date and June 4, 2021 (semaglutide users; date of initiation termed the index date) or participants with no evidence of semaglutide usage during January 1, 2016 to December 31, 2024 (non-users; a randomly selected date with ≥ 1 pharmacy claim on or after the eligibility date and June 4, 2021 will be termed the index date)
- 5\. Participant with continuous insurance enrolment eligibility more than or equal to (≥) 12 months prior to the index date (the baseline period)
- 6\. Participants with re-confirmed overweight/obesity indication during the baseline period
Exclusion
- 1\. Population specific exclusion criteria:
- HF and Clinical ASCVD Populations: Diagnosis of end-stage HF
- Primary Prevention Population: Diagnosis of HF or haemorrhagic stroke, or evidence of clinical ASCVD
- 2\. Participants with a diagnosis of chronic or acute pancreatitis
- 3\. Participants with a diagnosis of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- 4\. Participants with end-stage kidney disease (ESKD) including chronic or intermittent haemodialysis or peritoneal dialysis and/or kidney transplant
- 5\. More than or equal to (≥ 2) diagnoses of cancer (excluding non-melanoma skin cancer)
- 6\. Pregnancy in female participants
- 7\. Evidence of diabetes including more than or equal to (≥) 2 diagnoses of type 1 diabetes or more than or equal to (≥) 2 diagnoses of type 2 diabetes on distinct dates, use of a glucose-lowering agent, and/or glycated haemoglobin (HbA1c) laboratory result more than or equal to ≥ 6.5 percent (%)
- 8\. Use of a glucagon-like peptide-1 (GLP-1) or GLP-1/gastric inhibitory polypeptide (GIP) receptor agonist approved for weight management during the baseline period
- 9\. Participants with evidence of bariatric surgery
Key Trial Info
Start Date :
August 29 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 19 2025
Estimated Enrollment :
285327 Patients enrolled
Trial Details
Trial ID
NCT07141914
Start Date
August 29 2025
End Date
December 19 2025
Last Update
October 8 2025
Active Locations (1)
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1
Novo Nordisk Investigational
Plainsboro, New Jersey, United States, 08536