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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1221-9644 | Other Identifier | World Health Organization (WHO) | |
| 2018-003923-13 | Registry Identifier | European Medicines Agency (EudraCT) |
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The trial was terminated for strategic reasons.
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The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 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 they are pregnant, breast-feeding or planning to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DV3396 | Experimental | Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product) |
|
| PDS290 | Active Comparator | Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide (administered by DV3396 pen) | Drug | Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 21 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168h,2.4mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 2.4 mg | h*nmol/L | 0-168 hours (Day 141-148) after last 2.4 mg dose |
| Cmax,2.4mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 2.4 mg | nmol/L | 0-168 hours (Day 141-148) after last 2.4 mg dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168h,1mg,SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. 1 mg | h*nmol/L | 0-168 hours (Day 78-85) after last 1 mg dose |
| Cmax,1mg,SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. 1 mg |
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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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mainz | 55116 | Germany | |||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Semaglutide (administered by PDS290 pen) | Drug | Increasing doses of semaglutide given sc in the stomach for 21 weeks |
|
nmol/L |
| 0-168 hours (Day 78-85) after last 1 mg dose |
| Tmax,2.4mg,SS: Time of maximum observed semaglutide concentration after last 2.4 mg dose | h | 0-168 hours (Day 141-148) after last 2.4 mg dose |
| Tmax,1mg,SS: Time of maximum observed semaglutide concentration after last 1 mg dose | h | 0-168 hours (Day 78-85) after last 1 mg dose |
| t½: Terminal elimination half-life of semaglutide after last 2.4 mg dose | h | 0-1176 hours (Day 141-190) after last 2.4 mg dose |
| Cl/F2.4mg: Total apparent clearance of semaglutide after last 2.4 mg dose | L/h | 0-168 hours (Day 141-148) after last 2.4 mg dose |
| Cl/F1mg: Total apparent clearance of semaglutide after last 1 mg dose | L/h | 0-168 hours (Day 78-85) after last 1 mg dose |
| Vss/F2.4mg: Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose | L | 0-168 hours (Day 141-148) after last 2.4 mg dose |
| Vss/F1mg: Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose | L | 0-168 hours (Day 78-85) after last 1 mg dose |
| Change in body weight | percent | From baseline (Day 1, pre-dose) until the end of treatment (Day 148) |
| Neuss |
| 41460 |
| Germany |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C000591245 | semaglutide |
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