Phase 3 · Semaglutide

SELECT trial results

SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity

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 (Participants), From randomisation (week 0) up to 240 weeks. Semaglutide: 569; Placebo: 701.

Participants
17,604
Status
completed
Completed
2023-06-29
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT03574597), updated at source Aug 30, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SELECT measured first

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 StrokeParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
569701
Side effects by arm

Side effects in SELECT

Percent of participants affected, From randomisation (week 0) up to 240 weeks. The most common events the registry lists.

EventSemaglutidePlacebo
Any serious event33.4%36.4%
COVID-1920.3%20.3%
Nausea18.1%3.8%
Diarrhoea10.6%4%
Constipation8.1%2.6%
Decreased appetite6.6%1.3%
Vomiting6.5%1%
Dyspepsia5.3%1.1%
Secondary outcomes

What else it measured

Participants From Time of Randomisation to CV DeathParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
223262
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 DeathParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
300361
Participants From Time of Randomisation to All-cause DeathParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
375458
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 HospitalisationParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
8731074
Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal StrokeParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
710877
Participants From Time of Randomisation to First Occurrence of Non-fatal MIParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
234322
Participants From Time of Randomisation to First Occurrence of Non-fatal StrokeParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
154165
Participants From Time of Randomisation to First Occurrence of Coronary RevascularisationParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
473608
Participants From Time of Randomisation to First Occurrence of UAP Requiring HospitalisationParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
109124
Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF VisitParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
97122
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 [%])Participants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,800Placebon=8,797
3061059
Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome MeasureParticipants · From randomisation (week 0) up to 240 weeks · count of participants
Semaglutiden=8,803Placebon=8,801
155198
The trial

How SELECT was run

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.

  • 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 (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.
Who could join the trial

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

Published papers

Papers from SELECT

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.