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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1241-6257 | Other Identifier | World Health Organization (WHO) | |
| 2019-004020-37 | Registry Identifier | European Medicines Agency (EudraCT) |
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The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. 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 0.68 mg/mL | Experimental | Semaglutide administered with the PDS290 pen-injector |
|
| Semaglutide 1.0 mg/mL | Experimental | Semaglutide administered with the PDS290 pen-injector |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Two doses of semaglutide given by subcutaneous (s.c., under the skin) injection with different drug product concentration and separated by 6 to 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide plasma concentration curve from 0 to tz | h*nmol/L | 0-840 hours |
| Maximum semaglutide plasma concentration | nmol/L | 0-840 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide plasma concentration curve | h*nmol/L | 0-840 hours |
| Time to Cmax for semaglutide | h | 0-840 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor & Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Neuss | 41460 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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
| Terminal elimination half-life | h | 0-840 hours |
| Total apparent clearance of semaglutide | L/h | 0-840 hours |
| Apparent volume of distribution of semaglutide | L | 0-840 hours |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |