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SCORE

Completed

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

45,456

actual

Study population

Cardiovascular disease, Obesity / overweight

Key I/E criterion

Established ASCVD

Primary endpoints

5-point MACE (Myocardial infarction (any), Stroke (any), Heart-failure hospitalization, Coronary revascularization)Expanded / custom MACE composite (Myocardial infarction (any), Stroke (any), All-cause death)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06874751
Org study IDNN9536-8515
Secondary IDU1111-1318-9978World Health Organization (WHO)

Timeline

Milestones

Study start2024-12-06actual
Study first posted2025-03-13actual
Primary completion2025-03-28actual
Study completion2025-03-28actual
Last update posted2025-05-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age45 Years
SexAll
Sampling methodNon probability sample

Study population text

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).

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
9
Heart failure
1

Cardiovascular outcomes

9 endpoints
Primary/protocol endpoint

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

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

5-point MACE

time to event, event

componentsMyocardial infarction (any), Stroke (any), Heart-failure hospitalization, Coronary revascularization, All-cause death

Primary/protocol endpoint

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

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

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Stroke (any), All-cause death

Secondary/protocol endpoint

MI (time-to-event)

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

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Stroke (time-to-event)

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

Stroke (any)

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

Coronary revascularization (time-to-event)

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

Coronary revascularization

time to event, event

SNOMED 415070008

Secondary/protocol endpoint

All-cause mortality (time-to-event)

Time frame:Index date, end of follow up, up to 30 months

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

MACE-5

Time frame:Index date, earliest of MACE-5 and end of follow-up, up to 30 months

5-point MACE

time to event, event

componentsMyocardial infarction (any), Stroke (any), Heart-failure hospitalization, Coronary revascularization, Cardiovascular death

Secondary/protocol endpoint

MACE-3

Time frame:Index date, earliest of MACE-3 and end of follow-up, up to 30 months

3-point MACE

time to event, event

componentsCardiovascular death, Myocardial infarction (any), Stroke (any)

Secondary/protocol endpoint

CV-related mortality (time-to-event)

Time frame:Index date, earliest of MACE-3 and end of follow-up, up to 30 months

Cardiovascular death

time to event, event

Heart failure

1 endpoint
Secondary/protocol endpoint

Hospitalization for HF (time-to-event)

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

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.