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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1215-4058 | Other Identifier | World Health Organization (WHO) | |
| 2018-002289-38 | Registry Identifier | European Medicines Agency (EudraCT) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Semaglutide injected once-weekly. Standard dose escalations every 4 weeks will be applied, until the maximum dose of 1.0 mg semaglutide is reached. |
|
| Placebo | Placebo Comparator | Placebo injected once-weekly. Standard dose escalations every 4 weeks will be applied, until the maximum dose of 1.0 mg placebo is reached. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries | Ratio | From baseline (from 41 days before randomisation) to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries | Ratio | From baseline (from 40 days before randomisation) to week 26 |
| Change in total wall volume of the most diseased carotid artery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Unit / Center for Medical Research | Graz | 8010 | Austria | |||
| Steno Diabetes Center Copenhagen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40345413 | Derived | James S, Christoffersen AD, David JP, Hacker M, Jensen MDRJ, Mellbin L, Pieber TR, Ripa RS, Rossing P, Svehlikova E, Kjaer A. Effect of once-weekly subcutaneous semaglutide on arterial inflammation in people with type 2 diabetes and cardiovascular disease using PET-MRI: Primary results of a randomized, double-blind, placebo-controlled trial. Am Heart J. 2025 Nov;289:17-27. doi: 10.1016/j.ahj.2025.05.001. Epub 2025 May 7. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures
| 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). |
|
mm3
| From baseline (from 41 days before randomisation) to week 52 |
| Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery | mm3 | From baseline (from 41 days before randomisation) to week 52 |
| Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery | mm | From baseline (from 41 days before randomisation) to week 52 |
| Herlev |
| 2730 |
| Denmark |
| Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl | Stockholm | 171 64 | Sweden |
| CTC Clinical Trial Consultants AB, Uppsala | Uppsala | 75237 | Sweden |
| D004700 | Endocrine System Diseases |