NCT03914326

A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,651 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Semaglutide	Increasing doses (3 mg/7 mg/14 mg) of semaglutide tablets to be taken with water at the same time every morning in a fasting state
DRUG	Placebo (semaglutide)	Placebo tablets to be taken with water at the same time every morning in a fasting state

Timeline

• Start date: 2019-06-17
• Primary completion: 2024-08-23
• Completion: 2024-08-23
• First posted: 2019-04-16
• Last updated: 2025-12-11
• Results posted: 2025-09-22

Locations

492 sites across 34 countries: United States, Algeria, Argentina, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czechia, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study