GLPwatch

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

NCT03574597 · Completed

Last updated 2026-05-28

This clinical trial is testing whether the medication semaglutide can reduce the risk of heart disease and stroke in adults who are overweight or have obesity.

Status Completed The study has finished.
Phase Phase 3 Confirms effectiveness in a large group before approval.
Type Interventional (clinical trial)
Design Randomized, quadruple-blind treatment study
Participants 17,604 people
Who can join Ages 45+ · all sexes
Timeline Started 2018-10 · est. completion 2023-06
Where 833 sites · 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, Puerto Rico, Romania, Russia, Serbia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT03574597 ↗

Description as written by the study sponsor.

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.

Treatments tested

Main thing measuredParticipants 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
SponsorNovo Nordisk A/S
Conditions studiedOverweight, Obesity
GLP-1 drugs semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03574597 ↗