NCT03574597

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17,604 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide	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.
DRUG	Placebo (semaglutide)	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.

Timeline

• Start date: 2018-10-24
• Primary completion: 2023-06-21
• Completion: 2023-06-29
• First posted: 2018-07-02
• Last updated: 2024-08-30
• Results posted: 2024-08-30

Locations

833 sites across 42 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, Puerto Rico, Romania, Russia, Serbia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study