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

NCT06874751 | Completed

• 2 other identifiers: NN9536-8515U1111-1318-9978
• Study Type: observational
• Target: 45,456
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight; Obesity; Atherosclerotic Cardiovascular Disease (ASCVD)

Outcome Measures

Primary Outcomes (2)

• Revised 5-Point Major Adverse Cardiovascular Events (MACE-5) (time-to-event)

  Measured as months Occurrence of any of the following individual component events: 1. Myocardial Infarction (MI) 2. Stroke 3. Hospitalization for Heart Failure (HF) 4. Coronary revascularization 5. All-cause mortality The event date will be the earliest occurrence of one of the individual components.

  Index date, earliest of revised MACE-5 and end of follow-up, up to 30 months

• Revised 3-Point Major Adverse Cardiovascular Events (MACE-3) (time-to-event)

  Measured as months Occurrence of any of the following individual component events: 1. MI 2. Stroke 3. All-cause mortality The event date will be the earliest occurrence of one of the individual components.

  Index date, earliest of revised MACE-3 and end of follow-up, up to 30 months

Secondary Outcomes (8)

• MI (time-to-event)

  Index date, earliest of MI and end of follow-up, up to 30 months

• Stroke (time-to-event)

  Index date, earliest of stroke and end of follow-up, up to 30 months

• Hospitalization for HF (time-to-event)

  Index date, earliest of hospitalization for HF and end of follow up, up to 30 months

• Coronary revascularization (time-to-event)

  Index date, earliest of hospitalization for Coronary revascularization and end of follow up, up to 30 months

• All-cause mortality (time-to-event)

  Index date, end of follow up, up to 30 months

Study Arms (2)

Cohort: Semaglutide Users

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).

Other: No treatment given

Cohort: Semaglutide Non-users

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

Other: No treatment given

Interventions

No treatment given OTHER

No treatment given

Cohort: Semaglutide Users

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants, age above or equal to 45 years with overweight or obesity and established ASCVD will be included in the study. The eligibility date will be defined as the latest of the following dates: first overweight/ obesity ascertainment, first ASCVD diagnosis, and date participant reached age 45. Then, these participants will be divided into those who initiated semaglutide 2.4 mg (semaglutide 2.4 mg users) and those who did not (non-users).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Location

Related Publications (1)

• Smolderen KG, Mena-Hurtado C, Zhao Z, Michalak W, Faurby M, Smolarz BG, Kosiborod MN, Song J, Chen Y, Boland J, Nanna MG. Lower risk of cardiovascular events in patients initiated on semaglutide 2.4 mg in the real-world: Results from the SCORE study (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity in the Real World). Diabetes Obes Metab. 2025 Nov;27(11):6691-6704. doi: 10.1111/dom.70080. Epub 2025 Sep 9.

  PMID: 40926360 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Atherosclerosis

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 13, 2025
• Study Start: December 6, 2024
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)