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SELECT
CompletedPhase 3Results postedSemaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
833
Recruiting sites
—
Enrollment
17,604
actual
Study population
Cardiovascular disease, Obesity / overweight
Key I/E criteria
•BMI ≥27•Established CVD
Primary endpoint
•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)
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
Inclusion criteria
Exclusion criteria
Cardiovascular-related:
Glycaemia-related:
General safety:
Endpoints (58)
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
18 endpointsParticipants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Time frame:From randomisation (week 0) up to 240 weeks
3-point MACE
time to event, event
componentsCardiovascular death, Non-fatal MI, Non-fatal stroke
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 569 | — |
| Placebo | 701 | — |
Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Time frame:From randomisation (week 0) up to 240 weeks
3-point MACE
time to event, event
componentsCardiovascular death, Non-fatal MI, Non-fatal stroke
Participants From Time of Randomisation to CV Death
Time frame:From randomisation (week 0) up to 240 weeks
Cardiovascular death
time to event, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 223 | — |
| Placebo | 262 | — |
Participants From Time of Randomisation to All-cause Death
Time frame:From randomisation (week 0) up to 240 weeks
All-cause death
time to event, event
SNOMED 419620001
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 375 | — |
| Placebo | 458 | — |
Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation
Time frame:From randomisation (week 0) up to 240 weeks
Expanded / custom MACE composite
time to event, event
componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Coronary revascularization, Unstable angina hospitalization
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 873 | — |
| Placebo | 1074 | — |
Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke
Time frame:From randomisation (week 0) up to 240 weeks
Expanded / custom MACE composite
time to event, event
componentsAll-cause death, Non-fatal MI, Non-fatal stroke
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 710 | — |
| Placebo | 877 | — |
Participants From Time of Randomisation to First Occurrence of Non-fatal MI
Time frame:From randomisation (week 0) up to 240 weeks
Non-fatal MI
time to event, event
SNOMED 22298006
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 234 | — |
| Placebo | 322 | — |
Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke
Time frame:From randomisation (week 0) up to 240 weeks
Non-fatal stroke
time to event, event
SNOMED 230690007
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 154 | — |
| Placebo | 165 | — |
Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation
Time frame:From randomisation (week 0) up to 240 weeks
Coronary revascularization
time to event, event
SNOMED 415070008
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 473 | — |
| Placebo | 608 | — |
Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation
Time frame:From randomisation (week 0) up to 240 weeks
Unstable angina hospitalization
time to event, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 109 | — |
| Placebo | 124 | — |
Participants From Time of Randomisation to CV Death
Time frame:From randomisation (week 0) up to 240 weeks
Cardiovascular death
time to event, event
Participants From Time of Randomisation to All-cause Death
Time frame:From randomisation (week 0) up to 240 weeks
All-cause death
time to event, event
SNOMED 419620001
Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation
Time frame:From randomisation (week 0) up to 240 weeks
5-point MACE
time to event, event
componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Coronary revascularization, Unstable angina hospitalization
Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke
Time frame:From randomisation (week 0) up to 240 weeks
Expanded / custom MACE composite
time to event, event
componentsAll-cause death, Non-fatal MI, Non-fatal stroke
Participants From Time of Randomisation to First Occurrence of Non-fatal MI
Time frame:From randomisation (week 0) up to 240 weeks
Non-fatal MI
time to event, event
SNOMED 22298006
Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke
Time frame:From randomisation (week 0) up to 240 weeks
Non-fatal stroke
time to event, event
SNOMED 230690007
Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation
Time frame:From randomisation (week 0) up to 240 weeks
Coronary revascularization
time to event, event
SNOMED 415070008
Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation
Time frame:From randomisation (week 0) up to 240 weeks
Unstable angina hospitalization
time to event, event
Weight & body composition
4 endpointsChange in Body Weight
Time frame:Week 0, week 104
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), percentage change in body weight | 95% CI |
|---|---|---|
| Semaglutide | -9.39 | — |
| Placebo | -0.87 | — |
Change in Waist Circumference
Time frame:Week 0, week 104
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), centimeter (cm) | 95% CI |
|---|---|---|
| Semaglutide | -7.5 | — |
| Placebo | -1.0 | — |
Change in Body Weight
Time frame:Week 0, week 104
Body weight, % change
percent change from baseline, improvement
Change in Waist Circumference
Time frame:Week 0, week 104
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
10 endpointsParticipants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%])
Time frame:From randomisation (week 0) up to 240 weeks
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 306 | — |
| Placebo | 1059 | — |
Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%])
Time frame:From randomisation (week 0) up to 240 weeks
HbA1c <5.7% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 623 | — |
| Placebo | 1501 | — |
Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%])
Time frame:At week 52, week 104
HbA1c <5.7% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| SemaglutideWeek 52 | 3363 | — |
| Week 104 | 3271 | — |
| PlaceboWeek 52 | 955 | — |
| Week 104 | 978 | — |
Change in HbA1c - Percentage
Time frame:Week 0, week 104
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage of HbA1c | 95% CI |
|---|---|---|
| Semaglutide | -0.31 | — |
| Placebo | 0.01 | — |
Change in HbA1c - mmol/Mol
Time frame:Week 0, week 104
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), mmol/mol | 95% CI |
|---|---|---|
| Semaglutide | -3.38 | — |
| Placebo | 0.10 | — |
Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%])
Time frame:From randomisation (week 0) up to 240 weeks
HbA1c <6.5% achievement
time to event, event
LOINC 4548-4
Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%])
Time frame:From randomisation (week 0) up to 240 weeks
HbA1c <5.7% achievement
threshold achievement, improvement
LOINC 4548-4
Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%])
Time frame:At week 52, week 104
HbA1c <5.7% achievement
threshold achievement, improvement
LOINC 4548-4
Change in HbA1c - Percentage
Time frame:Week 0, week 104
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c - mmol/Mol
Time frame:Week 0, week 104
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Heart failure
4 endpointsParticipants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death
Time frame:From randomisation (week 0) up to 240 weeks
Expanded / custom MACE composite
time to event, event
componentsHeart-failure hospitalization, Urgent heart-failure visit, Cardiovascular death
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 300 | — |
| Placebo | 361 | — |
Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit
Time frame:From randomisation (week 0) up to 240 weeks
Heart-failure composite
time to event, event
componentsHeart-failure hospitalization, Urgent heart-failure visit
SNOMED 84114007
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 97 | — |
| Placebo | 122 | — |
Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death
Time frame:From randomisation (week 0) up to 240 weeks
Expanded / custom MACE composite
time to event, event
componentsHeart-failure hospitalization, Urgent heart-failure visit, Cardiovascular death
Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit
Time frame:From randomisation (week 0) up to 240 weeks
Heart-failure composite
time to event, event
componentsHeart-failure hospitalization, Urgent heart-failure visit
SNOMED 84114007
Renal / kidney
2 endpointsParticipants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure
Time frame:From randomisation (week 0) up to 240 weeks
5-point renal composite
time to event, event
componentsuACR, change, eGFR, change, End-stage renal disease, Kidney-replacement therapy, Renal death
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Semaglutide | 155 | — |
| Placebo | 198 | — |
Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure
Time frame:From randomisation (week 0) up to 240 weeks
5-point renal composite
time to event, event
componentsuACR, change, eGFR, change, End-stage renal disease, Kidney-replacement therapy, Renal death
Cardiometabolic biomarkers
16 endpointsChange in Systolic Blood Pressure (SBP)
Time frame:Week 0, week 104
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), Millimetre of mercury (mmHg) | 95% CI |
|---|---|---|
| Semaglutide | -3.8 | — |
| Placebo | -0.6 | — |
Change in Diastolic Blood Pressure (DBP)
Time frame:Week 0, week 104
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Semaglutide | -1.1 | — |
| Placebo | -0.4 | — |
Change in Pulse
Time frame:Week 0, week 104
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), beats per mintue (bpm) | 95% CI |
|---|---|---|
| Semaglutide | 3.8 | — |
| Placebo | 0.9 | — |
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Time frame:Week 0, week 104
hs-CRP, change
ratio, improvement
LOINC 30522-7
Posted result
| Group | Value (geometric_mean), ratio of hsCRP | 95% CI |
|---|---|---|
| Semaglutide | 0.61 | — |
| Placebo | 1.00 | — |
Change in Total Cholesterol - Ratio to Baseline
Time frame:Week 0, week 104
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Value (geometric_mean), ratio of total cholesterol | 95% CI |
|---|---|---|
| Semaglutide | 0.95 | — |
| Placebo | 0.98 | — |
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Time frame:Week 0, week 104
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Value (geometric_mean), ratio of HDL | 95% CI |
|---|---|---|
| Semaglutide | 1.05 | — |
| Placebo | 1.01 | — |
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Time frame:Week 0, week 104
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Value (geometric_mean), ratio of LDL | 95% CI |
|---|---|---|
| Semaglutide | 0.95 | — |
| Placebo | 0.97 | — |
Change in Triglycerides - Ratio to Baseline
Time frame:Week 0, week 104
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Value (geometric_mean), ratio of triglycerides | 95% CI |
|---|---|---|
| Semaglutide | 0.82 | — |
| Placebo | 0.97 | — |
Change in Systolic Blood Pressure (SBP)
Time frame:Week 0, week 104
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Change in Diastolic Blood Pressure (DBP)
Time frame:Week 0, week 104
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Change in Pulse
Time frame:Week 0, week 104
Heart rate, change
change from baseline, improvement
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Time frame:Week 0, week 104
hs-CRP, change
ratio, improvement
LOINC 30522-7
Change in Total Cholesterol - Ratio to Baseline
Time frame:Week 0, week 104
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Time frame:Week 0, week 104
HDL-C, change
ratio, improvement
LOINC 2085-9
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Time frame:Week 0, week 104
LDL-C, change
ratio, improvement
LOINC 13457-7
Change in Triglycerides - Ratio to Baseline
Time frame:Week 0, week 104
Triglycerides, change
ratio, improvement
LOINC 2571-8
Patient-reported / QoL
4 endpointsChange From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104
Time frame:Week 0, week 104
EQ-5D index
change from baseline, improvement
Posted result
| Group | Value (mean), score on a scale | 95% CI |
|---|---|---|
| Semaglutide | 0.01 | — |
| Placebo | -0.01 | — |
Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104
Time frame:Week 0, week 104
EQ-5D VAS
change from baseline, improvement
Posted result
| Group | Value (mean), score on a scale | 95% CI |
|---|---|---|
| Semaglutide | 2.38 | — |
| Placebo | 0.77 | — |
Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104
Time frame:Week 0, week 104
EQ-5D index
change from baseline, improvement
Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104
Time frame:Week 0, week 104
EQ-5D VAS
change from baseline, improvement
Publications (22)
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.
Canonical study publications
- The New England journal of medicine2023 Dec 14PMID37952131doi:10.1056/NEJMoa2307563via CT.gov reference + pubmed nct search
Registry references + supporting bibliography
- Journal of medical economics2026 Dec (month)PMID41562647doi:10.1080/13696998.2026.2615606via pubmed nct search
- Nature medicine2026 Apr 2PMID41928037doi:10.1038/s41591-026-04281-1via clinicaltrials gov reference derived + pubmed nct search
- JAMA cardiology2026 Feb 1PMID41433034doi:10.1001/jamacardio.2025.4824via clinicaltrials gov reference derived + pubmed nct search
- Journal of medical economics2025 Dec (month)PMID39882599doi:10.1080/13696998.2025.2459529via clinicaltrials gov reference derived + pubmed nct search
- Lancet (London, England)2025 Nov 8PMID41138739doi:10.1016/S0140-6736(25)01375-3via clinicaltrials gov reference derived + pubmed nct search
- Advances in therapy2025 May (month)PMID40156748doi:10.1007/s12325-025-03176-wvia clinicaltrials gov reference derived + pubmed nct search
- Clinical journal of the American Society of Nephrology : CJASN2025 Feb 1PMID39480988doi:10.2215/CJN.0000000584via clinicaltrials gov reference derived + pubmed nct search
- The lancet. Diabetes & endocrinology2025 Jan (month)PMID39608381doi:10.1016/S2213-8587(24)00271-7via clinicaltrials gov reference derived + pubmed nct search
- Journal of the American College of Cardiology2024 Oct 22PMID39217559doi:10.1016/j.jacc.2024.08.007via clinicaltrials gov reference derived + pubmed nct search
- Lancet (London, England)2024 Sep 7PMID39222642doi:10.1016/S0140-6736(24)01643-Xvia clinicaltrials gov reference derived + pubmed nct search
- Lancet (London, England)2024 Aug 24PMID39181597doi:10.1016/S0140-6736(24)01498-3via clinicaltrials gov reference derived + pubmed nct search
- Nature medicine2024 Jul (month)PMID38796653doi:10.1038/s41591-024-03015-5via clinicaltrials gov reference derived + pubmed nct search
- Nature medicine2024 Jul (month)PMID38740993doi:10.1038/s41591-024-02996-7via clinicaltrials gov reference derived + pubmed nct search
- American journal of preventive cardiology2023 Jun (month)PMID37313358doi:10.1016/j.ajpc.2023.100502via pubmed nct search
- Hepatology (Baltimore, Md.)2023 Jun 1PMID36738088doi:10.1097/HEP.0000000000000327via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2022 Aug (month)PMID35373878doi:10.1111/dom.14707via clinicaltrials gov reference derived + pubmed nct search
- Current opinion in cardiology2022 Jul 1PMID35175229doi:10.1097/HCO.0000000000000955via clinicaltrials gov reference derived + pubmed nct search
- The Cochrane database of systematic reviews2021 Oct 25PMID34693515doi:10.1002/14651858.CD013650.pub2via clinicaltrials gov reference derived + pubmed nct search
- The New England journal of medicine2021 Mar 18PMID33567185doi:10.1056/NEJMoa2032183via CT.gov reference
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.