Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity in the Real World (SCORE)

Novo Nordisk

Status: Completed

Conditions: Atherosclerotic Cardiovascular Disease (ASCVD); Overweight; Obesity

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT06874751

U1111-1318-9978 (Other Identifier)

NN9536-8515

Details and patient eligibility

About

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 of once-weekly semaglutide 2.4 mg in reducing the risk of CV and other obesity-related clinical outcomes.

Enrollment: 45,456 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

45,456 participants in 2 patient groups

Cohort: Semaglutide Users

Description:

Participants age above or equal to (≥) 45 years with overweight or obesity and established ASCVD who initiated semaglutide 2.4 mg (semaglutide 2.4 mg users).

Treatment:

Other: No treatment given

Other: No treatment given

Cohort: Semaglutide Non-users

Description:

Participants age above or equal to (≥) 45 years with overweight or obesity and established ASCVD who are semaglutide 2.4 mg non-users.

Treatment:

Other: No treatment given

Other: No treatment given