Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
NCT03574597 · Completed
Last updated 2026-05-28This 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.
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
- Semaglutide Drug
Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.
- Placebo (semaglutide) Drug
Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.
| Main thing measured | 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 |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Conditions studied | Overweight, Obesity |
| GLP-1 drugs | semaglutide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03574597 ↗