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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1321-8655 | Other Identifier | World Health Organization (WHO) | |
| 2025-522920-28 | Other Identifier | European Medical Agency (EMA) |
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The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight. Participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to treat people with type 2 diabetes and excess body weight) or placebo (a placebo looks like the treatment being tested but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants will be in this clinical study up to 15 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema | Experimental | Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) for up to 52 weeks. |
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| Semaglutide | Experimental | Participants will receive once weekly s.c. dose of semaglutide for up to 52 weeks. |
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| Cagrilintide | Experimental | Participants will receive once weekly s.c. dose of cagrilintide for up to 52 weeks. |
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| Placebo | Placebo Comparator | Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide for up to 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Participants will receive cagrilintide subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle | Measured in micromoles per 100 grams per minute (μmol/100g/min). | Baseline to Week 51 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin-stimulated FDG uptake in skeletal muscle | Measured in μmol/100g/min. | Baseline to Week 20 |
| Change in insulin-stimulated FDG uptake in skeletal muscle | Measured in μmol/100g/min. |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitetshospital, Steno Diabetes Center Aarhus | Recruiting | Aarhus N | 8200 | Denmark |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Semaglutide | Drug | Participants will receive semaglutide subcutaneously. |
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| Placebo cagrilintide | Drug | Participants will receive placebo matched to cagrilintide subcutaneously. |
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| Placebo semaglutide | Drug | Participants will receive placebo matched to semaglutide subcutaneously. |
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| Baseline to Week 51 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
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