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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

Short name SELECT

NCTNCT03574597 (opens ClinicalTrials.gov in a new tab)Other idEX9536-4388Other id2017-003380-35Other idU1111-1200-5564Other id2017
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
17,604 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
30 countries

United States, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal

Start
24 Oct 2018
Primary completion
21 Jun 2023
Completion
29 Jun 2023
First posted
2 Jul 2018
Last update posted
30 Aug 2024
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021202220232024
  1. Ph 3

    SELECT

    NCT03574597

    24 Oct 2018 to 29 Jun 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

Interventions

  • SemaglutideDrug
  • Placebo (semaglutide)Drug

Arms2

  • Experimental

    Semaglutide

    Participants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.

  • Placebo comparator

    Placebo (semaglutide)

    Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    Number of participants with first occurrence of composite outcome measure consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

Secondary outcomes(20)

  1. Participants From Time of Randomisation to CV Death

    Time frame · From randomisation (week 0) up to 240 weeks

    Registry description

    Number of participants with CV death are presented. The outcome measure was evalulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  2. 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

    Registry description

    Number of participants with first occurrence of a composite HF outcome measure consisted of HF hospitalisation, urgent HF visit or CV death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  3. Participants From Time of Randomisation to All-cause Death

    Time frame · From randomisation (week 0) up to 240 weeks

    Registry description

    Number of participants with all-cause death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  4. 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

    Registry description

    Number of participants with first occurrence of an expanded composite CV outcome measure consisted of CV death, non-fatal MI, non-fatal stroke, coronary revascularisation or UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  5. 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

    Registry description

    Number of participants with first occurrence of a composite outcome measure consisted of all-cause death, non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  6. Participants From Time of Randomisation to First Occurrence of Non-fatal MI

    Time frame · From randomisation (week 0) up to 240 weeks

    Registry description

    Number of participants with first occurrence of non-fatal MI are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  7. Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke

    Time frame · From randomisation (week 0) up to 240 weeks

    Registry description

    Number of participants with first occurrence of non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  8. Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation

    Time frame · From randomisation (week 0) up to 240 weeks

    Registry description

    Number of participants with first occurrence of coronary revascularisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  9. Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation

    Time frame · From randomisation (week 0) up to 240 weeks

    Registry description

    Number of participants with first occurrence of UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  10. 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

    Registry description

    Number of participants with first occurrence of HF requiring hospitalisation or urgent HF visit are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  11. 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

    Registry description

    Number of participants with first occurrence of HbA1c ≥ 48 mmol/mol (6.5%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  12. 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

    Registry description

    Number of participants with first occurrence of a 5-component composite nephropathy outcome measure consisted of onset of persistent macroalbuminuria (UACR \> 300 milligram per gram \[mg/g\]), persistent 50% reduction in estimated glomerular filtration rate (eGFR) compared with baseline (randomisation), onset of persistent eGFR \< 15 ml/min/1.73m\^2, initiation of chronic renal replacement therapy (dialysis or transplantation) or renal death. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  13. 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

    Registry description

    Number of participants with HbA1c ≥ 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  14. 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

    Registry description

    Number of participants with HbA1c \< 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  15. Change in Systolic Blood Pressure (SBP)

    Time frame · Week 0, week 104

    Registry description

    Change in SBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  16. Change in Diastolic Blood Pressure (DBP)

    Time frame · Week 0, week 104

    Registry description

    Change in DBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  17. Change in Pulse

    Time frame · Week 0, week 104

    Registry description

    Change in pulse from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  18. Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline

    Time frame · Week 0, week 104

    Registry description

    Change in hsCRP (milligram per liter \[mg/L\]) from randomisation (week 0) to week 104 presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  19. Change in Total Cholesterol - Ratio to Baseline

    Time frame · Week 0, week 104

    Registry description

    Change in total cholesterol (milligram per deciliter \[mg/dL\]) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

  20. Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

    Time frame · Week 0, week 104

    Registry description

    Change in HDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· From randomisation (week 0) up to 240 weeks

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

GroupValue (Participants)
Semaglutide569
Placebo701
Secondary and other outcome results(7)
Secondary outcomeCount of participants· From randomisation (week 0) up to 240 weeks

Participants From Time of Randomisation to CV Death

GroupValue (Participants)
Semaglutide223
Placebo262
Secondary outcomeCount of participants· From randomisation (week 0) up to 240 weeks

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

GroupValue (Participants)
Semaglutide300
Placebo361
Secondary outcomeCount of participants· From randomisation (week 0) up to 240 weeks

Participants From Time of Randomisation to All-cause Death

GroupValue (Participants)
Semaglutide375
Placebo458
Secondary outcomeCount of participants· From randomisation (week 0) up to 240 weeks

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

GroupValue (Participants)
Semaglutide873
Placebo1074
Secondary outcomeCount of participants· From randomisation (week 0) up to 240 weeks

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

GroupValue (Participants)
Semaglutide710
Placebo877
Secondary outcomeCount of participants· From randomisation (week 0) up to 240 weeks

Participants From Time of Randomisation to First Occurrence of Non-fatal MI

GroupValue (Participants)
Semaglutide234
Placebo322
Secondary outcomeCount of participants· From randomisation (week 0) up to 240 weeks

Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke

GroupValue (Participants)
Semaglutide154
Placebo165

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SemaglutideParticipants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.371 / 88032941 / 88033944 / 8803
PlaceboParticipants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.460 / 88013204 / 88012440 / 8801

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies16

Studies that cite this trial.

Studies with results

11 studies on this page

Indexing hint: Randomized controlled trial · 2026

4 results

Semaglutide on liver fibrosis and heart outcomes in patients at high risk of liver fibrosis: a prespecified analysis of the SELECT randomized trial.

Meyhöfer et al. 2026Nature medicinecited by 4

PMID 41928037PMC13190271DOI 10.1038/s41591-026-04281-1PUB-41928037

CC BY4 results
Download PDFSee results (4)

Indexing hint: Randomized controlled trial · 2026

6 results

Effect of Semaglutide on the Inflammatory Biomarker High-Sensitivity CRP in Patients With Established Cardiovascular Disease and Overweight or Obesity in SELECT: A Prespecified Secondary Analysis.

Plutzky et al. 2026Circulation

PMID 42610271PMC13574348DOI 10.1161/circulationaha.125.074482PUB-42610271

CC BY6 results
Download PDFSee results (6)

Indexing hint: Clinical trial · 2025

12 results

Cost-effectiveness of semaglutide in people with obesity and cardiovascular disease without diabetes.

McEwan et al. 2025Journal of medical economicscited by 14

PMID 39882599DOI 10.1080/13696998.2025.2459529PUB-39882599

Full text at the publisher12 results
Publisher pageSee results (12)

Indexing hint: Randomized controlled trial · 2025

8 results

Semaglutide and cardiovascular outcomes by baseline and changes in adiposity measurements: a prespecified analysis of the SELECT trial.

Deanfield et al. 2025Lancet (London, England)cited by 103

PMID 41138739DOI 10.1016/s0140-6736(25)01375-3PUB-41138739

Full text at the publisher8 results
Publisher pageSee results (8)

Indexing hint: Randomized controlled trial · 2024

12 results

Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.

Ryan et al. 2024Nature medicinecited by 275

PMID 38740993PMC11271387DOI 10.1038/s41591-024-02996-7PUB-38740993

CC BY12 results
Download PDFSee results (12)

Indexing hint: Randomized controlled trial · 2024

3 results

Long-term kidney outcomes of semaglutide in obesity and cardiovascular disease in the SELECT trial.

Colhoun et al. 2024Nature medicinecited by 188

PMID 38796653PMC11271413DOI 10.1038/s41591-024-03015-5PUB-38796653

CC BY3 results
Download PDFSee results (3)

Indexing hint: Randomized controlled trial · 2024

10 results

Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial.

Deanfield et al. 2024Lancet (London, England)cited by 221

PMID 39181597DOI 10.1016/s0140-6736(24)01498-3PUB-39181597

Full text at the publisher10 results
Publisher pageSee results (10)

Indexing hint: Randomized controlled trial · 2024

9 results

The Effect of Semaglutide on Mortality and COVID-19-Related Deaths: An Analysis From the SELECT Trial.

Scirica et al. 2024Journal of the American College of Cardiologycited by 40

PMID 39217559DOI 10.1016/j.jacc.2024.08.007PUB-39217559

Full text at the publisher9 results
Publisher pageSee results (9)

Indexing hint: Randomized controlled trial · 2024

4 results

Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials.

Kosiborod et al. 2024Lancet (London, England)cited by 232

PMID 39222642DOI 10.1016/s0140-6736(24)01643-xPUB-39222642

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2023

2 results

Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.

Lincoff et al. 2023The New England journal of medicinecited by 2,458

PMID 37952131DOI 10.1056/nejmoa2307563PUB-37952131

Rights unknown2 results
Source linkSee results (2)

Indexing hint: Randomized controlled trial · 2021

10 results

Once-Weekly Semaglutide in Adults with Overweight or Obesity.

Wilding et al. 2021The New England journal of medicinecited by 3,862

PMID 33567185DOI 10.1056/nejmoa2032183PUB-33567185

Full text at the publisher10 results
Publisher pageSee results (10)

Indexing hint: Clinical trial · 2020

Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design.

Ryan et al. 2020American heart journalcited by 192

PMID 32916609DOI 10.1016/j.ahj.2020.07.008PUB-32916609

Full text at the publisher
Publisher page

More studies

4 studies on this page

Indexing hint: Randomized controlled trial · 2026

Corrected

Semaglutide and Hospitalizations in Patients With Obesity and Established Cardiovascular Disease: An Exploratory Analysis of the SELECT Randomized Clinical Trial.

Nicholls et al. 2026JAMA cardiologycited by 3

PMID 41433034PMC12728728DOI 10.1001/jamacardio.2025.4824PUB-41433034

Free to read · publisher termsCC BY-NC-ND
Read at sourceRead the notice

PubMed tag: none · 2026

Efficacy and Safety of Semaglutide According to Frailty Status: A Post Hoc Analysis of the SELECT Randomized Clinical Trial.

Ostrominski et al. 2026JAMA cardiology

PMID 42747817DOI 10.1001/jamacardio.2026.3566PUB-42747817

Full text at the publisher
Publisher page

PubMed tag: none · 2025

The Composite Number Needed to Treat for Semaglutide in Populations with Overweight or Obesity and Established Cardiovascular Disease Without Diabetes.

Lübker et al. 2025Advances in therapycited by 3

PMID 40156748PMC12006245DOI 10.1007/s12325-025-03176-wPUB-40156748

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Review · 2022

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity.

Mares et al. 2022Current opinion in cardiologycited by 9

PMID 35175229DOI 10.1097/hco.0000000000000955PUB-35175229

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedSisodia A. Predicting GLP-1 Discontinuation From Pharmacy Claims. Am J Manag Care. 2026 Aug;32(8):426-428. doi: 10.37765/ajmc.2026.89993. PMID 42663544
  • DerivedBadve SV, Bilal A, Lee MMY, Sattar N, Gerstein HC, Ruff CT, McMurray JJV, Rossing P, Bakris G, Mahaffey KW, Mann JFE, Colhoun HM, Tuttle KR, Pratley RE, Perkovic V. Effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes: a meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol. 2025 Jan;13(1):15-28. doi: 10.1016/S2213-8587(24)00271-7. Epub 2024 Nov 25. PMID 39608381
  • DerivedMendonca L, Moura H, Chaves PC, Neves JS, Ferreira JP. The Impact of Glucagon-Like Peptide-1 Receptor Agonists on Kidney Outcomes: A Meta-Analysis of Randomized Placebo-Controlled Trials. Clin J Am Soc Nephrol. 2025 Feb 1;20(2):159-168. doi: 10.2215/CJN.0000000584. Epub 2024 Oct 8. PMID 39480988
  • DerivedRowe IA, Allen AM. Hepatic steatosis provides the terroir that promotes the development of cardiovascular risk factors and disease. Hepatology. 2023 Jun 1;77(6):1843-1845. doi: 10.1097/HEP.0000000000000327. Epub 2023 Feb 6. No abstract available. PMID 36738088
  • DerivedLeite AR, Angelico-Goncalves A, Vasques-Novoa F, Borges-Canha M, Leite-Moreira A, Neves JS, Ferreira JP. Effect of glucagon-like peptide-1 receptor agonists on cardiovascular events in overweight or obese adults without diabetes: A meta-analysis of placebo-controlled randomized trials. Diabetes Obes Metab. 2022 Aug;24(8):1676-1680. doi: 10.1111/dom.14707. Epub 2022 May 3. PMID 35373878

Eligibility

Who could join, as posted.

Sex
All
Age
from 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, age greater than or equal to 45 years at the time of signing informed consent * Body mass index (BMI) greater than or equal to 27 kg/m\^2 * Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease Exclusion Criteria: Cardiovascular-related: * Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Presently classified as being in New York Heart Association (NYHA) Class IV heart failure Glycaemia-related: * HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes (history of gestational diabetes is allowed) * Treatment with glucose-lowering agents within 90 days before screening * Treatment with any glucagon-like-peptide-1 receptor agonist (GLP-1 RA) within 90 days before screening General safety: * History or presence of chronic pancreatitis * Presence of acute pancreatitis within the past 180 days prior to the day of screening * Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis * Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed * Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol * Known or suspected hypersensitivity to trial products or related products * Previous participation in this trial. Participation is defined as randomisation * Receipt of any investigational medicinal product within 30 days before screening * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method * Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol

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