Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06874751
Eligibility Criteria:
Inclusion Criteria:
1. 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
2. Participants with established ASCVD defined as a diagnosis of MI, diagnosis of ischemic stroke, and/or evidence of peripheral arterial disease
3. Participants who are above or equal to (≥) 45 years old by the end of data availability
4. 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
5. Participant with continuous insurance enrolment eligibility above or equal to (≥)12 months prior to the index date
6. Participants with re-confirmed overweight/obesity indication during the baseline period
Exclusion criteria:
1. Participants with a diagnosis of chronic or acute pancreatitis
2. Participants with a diagnosis of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
3. 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)
4. Pregnancy in female participants
5. 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 (%)
6. 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)
7. Participants with evidence of bariatric surgery
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT06874751
Study Brief:
Protocol Section:
NCT06874751