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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1215-9915 | Other Identifier | World Health Organization (WHO) | |
| 2018-002497-42 | Registry Identifier | European Medicines Agency (EudraCT) |
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This study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine. In addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake. Participants will either get semaglutide or "dummy" medicine - which treatment any participant gets is decided by chance. Participants will take 1 injection per week. The study medicine is injected with a thin needle in the stomach, thigh or upper arm. The study will last for about 27 weeks (from first treatment to last check-up). Participants will have 8 visits at the clinic with the study doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Participants will receive increasing doses of semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks. |
|
| Placebo (Semaglutide) | Placebo Comparator | Participants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Participants will receive gradually increasing doses of semaglutide (subcutaneous [s.c.], in the thigh, abdomen or upper arm) injection once weekly, until they reach a dose of level of 2.4 mg, which they will continue for 5 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state | Measured in h*micrograms/mL | 0 to 5 hours after standardised meal (day 142) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state | Measured in h*micrograms/mL | 0 to 1 hour after standardised meal (day 142) |
| Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours |
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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 | Berlin | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33269530 | Result | Friedrichsen M, Breitschaft A, Tadayon S, Wizert A, Skovgaard D. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab. 2021 Mar;23(3):754-762. doi: 10.1111/dom.14280. Epub 2021 Jan 3. |
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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.
| Placebo | Drug | Participants will receive once weekly injections of semaglutide matched placebo. |
|
Measured in micrograms/mL |
| 0 to 5 hours after standardised meal (day 142) |
| Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours | Measured in hours | 0 to 5 hours after standardised meal (day 142) |
| Energy intake during ad libitum lunch | Measured in kilojoules | Day 142 |
| Mean postprandial rating - Hunger (AUC30-300min/270 min) using visual analogue scales (VAS) from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 |
| Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 |
| Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 |
| Mean postprandial rating - Prospective food consumption (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 |
| Mean postprandial rating - Overall appetite score (OAS) (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal | Measured in mm, from 0-100. The ends of each line indicate the most extreme sensation respondents have experienced. | Day 142 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |