A Master Protocol for Semaglutide Effects on Cardiovascular and Obesity-related Outcomes in People With Overweight or Obesity in the Real World

NCT ID: NCT07141914

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 285327 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-29
• Study Completion Date: 2025-12-19

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), 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.

Conditions

Overweight; Obesity; Heart Failure (HF); Atherosclerotic Cardiovascular Disease (ASCVD); Primary Prevention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort: Semaglutide users

No treatment given

Intervention Type: OTHER

No treatment given

Cohort: Semaglutide Non-users

No treatment given

Intervention Type: OTHER

No treatment given

Interventions

No treatment given

No treatment given

Intervention Type: OTHER

No treatment given

No treatment given

Intervention Type: OTHER

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) 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

2. 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

1. Smoking history

2. Dyslipidaemia

3. Hypertension

4. Prediabetes

5. Chronic kidney disease (CKD) or evidence of kidney function decline/kidney damage

6. 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 Criteria

1. HF and Clinical ASCVD Populations: Diagnosis of end-stage HF

2. 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational

Plainsboro, New Jersey, United States

Countries

United States

Other Identifiers

U1111-1326-1795

Identifier Type: OTHER

Identifier Source: secondary_id

NN9536-8669

Identifier Type: -

Identifier Source: org_study_id