A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes
NCT04032197 · Completed
Last updated 2026-05-28This study is testing how the medication semaglutide affects inflammation in the arteries of adults who have both type 2 diabetes and a heart or blood vessel disease.
What this study is testing ClinicalTrials.gov NCT04032197 ↗
Description as written by the study sponsor.
This study looks into how the type 2 diabetes medicine, semaglutide, can prevent risk of heart disease complications and stroke. Participants will either get semaglutide or placebo ("dummy" medicine) - which treatment is decided by chance. Semaglutide is a new medicine to treat type 2 diabetes and can be prescribed by doctors in some countries. The study medicine will be in a pen, and must be injected with a needle in the stomach, thigh or upper arm once a week. The study will last for 57-63 weeks. Participants will have 10 clinic visits with the study doctor, 5 visits to the specialised clinic for imaging and at least 1 phone contact. Participants' health will be monitored carefully and blood samples will therefore be taken at the clinic visits. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Treatments tested
- Semaglutide Drug
Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).
- Placebo (semaglutide) Drug
Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).
| Main thing measured | Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Conditions studied | Diabetes Mellitus, Type 2 |
| GLP-1 drugs | semaglutide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04032197 ↗