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CompletedSemaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity in the Real World
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsRevised 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
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
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
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
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
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
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
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)
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 endpointHospitalization 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.
Registry references + supporting bibliography
- Diabetes, obesity & metabolism2025 Nov (month)PMID40926360doi:10.1111/dom.70080via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.