GLP-1 Evidence

Not medical advice. A record of published research and our assessments of it. The limits

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

Status
CompletedResults posted
Why it is watched
non-weight indication: cardiovascular, cerebrovascular
Who it enrolls
age 45 Years to no upper limit; excludes diabetes; no BMI minimum stated; conditions: Overweight; Obesity
Interventions
Semaglutide; Placebo (semaglutide)
Conditions
Overweight; Obesity
Phase and size
Phase 3 · 17604 participants
Dates
Start 2018-10-24
Primary completion 2023-06-21
Sponsor
Novo Nordisk A/S (Industry)
Last checked
Sep 13, 2026
01Endpoints

What the trial will measure

  • 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 StrokeFrom randomisation (week 0) up to 240 weeks

Published results in the collection

02Eligibility

Who can take part

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
03Change log

Registry changes

No changes recorded since the trial was added.