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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003341-38 | EudraCT Number | ||
| U1111-1266-4375 | Other Identifier | World Health Organization (WHO) |
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This study tests if semaglutide tablets of 50 mg can help people with obesity to lower their food intake compared to placebo. This study also tests how semaglutide 50 mg works on appetite, control of eating (such as cravings and restraints) and how long time the food stays in the stomach after a meal.
In addition, how much semaglutide is in the blood will also be tested. Participants will either get semaglutide or placebo - which treatment participants will get is decided by chance. Participants will receive one semaglutide (or placebo) tablet per day during the 20-week treatment period. The dose of semaglutide is slowly increased every 4 weeks during the study to reach the treatment dose of 50 mg semaglutide taken for 4 weeks.
The study lasts for up to 29 weeks for each person and includes a screening period (up to 4 weeks), a treatment period (20 weeks) and a follow-up period (total of 5 weeks after the last dosing). Participants will have 12 visits with the study doctors at the institute.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide D Dose 1 | Drug | Tablet given orally |
| |
| Semaglutide D Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in energy intake during ad libitum lunch | Measured in Percentage | Baseline to Day 140 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in energy intake during ad libitum lunch | Measured in kJ | Baseline to Day 140 |
| Change in amount of food consumed during ad libitum lunch | Measured in g |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39082206 | Result | Gabe MBN, Breitschaft A, Knop FK, Hansen MR, Kirkeby K, Rathor N, Adrian CL. Effect of oral semaglutide on energy intake, appetite, control of eating and gastric emptying in adults living with obesity: A randomized controlled trial. Diabetes Obes Metab. 2024 Oct;26(10):4480-4489. doi: 10.1111/dom.15802. Epub 2024 Jul 31. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Drug |
Tablet given orally |
|
| Semaglutide D Dose 3 | Drug | Tablet given orally |
|
| Semaglutide C Dose 4 | Drug | Tablet given orally |
|
| Semaglutide C Dose 5 (50 mg) | Drug | Tablet given orally |
|
| Placebo (Semaglutide C) | Drug | Tablet given orally |
|
| Placebo ( Semaglutide D) | Drug | Tablet given orally |
|
| Baseline to Day 140 |
| Change in body weight | Measured in Percentage | Baseline to Day 141 |
| AUC0-5h,para | Measured in h*μg/mL | 0-5h after standardised meal, Day 141 |
| AUC0-1h,para | Measured in h*μg/mL | 0-1h after standardised meal, Day 141 |
| Cmax,para | Measured in μg/mL | 0-5h after standardised meal, Day 141 |
| tmax,para | Measured in h | 0-5h after standardised meal, Day 141 |
| Mean postprandial rating - hunger | Measured in mm | Day 140 |
| Mean postprandial rating - fullness | Measured in mm | Day 140 |
| Mean postprandial rating - satiety | Measured in mm | Day 140 |
| Mean postprandial rating - prospective food consumption | Measured in mm | Day 140 |
| Mean postprandial rating - overall appetite score (OAS) | Measured in mm | Day 140 |
| Food cravings assessed by Control of Eating Questionnaire (COEQ) | Measured in mm | Day 139 |
| AUC0-24h,sema,50mg,ss area under these semaglutide-time curve (0-24h) during a dosing interval at steady state | Measured in nmol*h/L | Day 140 to 141 |
| Cmax,sema,50mg,ss maximum concentration at steady state of semaglutide 50 mg | Measured in nmol*h/L | Day 140 to 175 |
| tmax,sema,50mg,ss from last dosing to maximum concentration of semaglutide at steady state for semaglutide 50 mg | Measured in h | Day 140 to 175 |
| t½,sema,50mg,SS terminal half-life of the log concentration time curve | Measured in h | Day 140 to 175 |
| CL/Fsema,50mg,ss total apparent clearance for semaglutide 50 mg at steady state | Measured in L/h | Day 140 to 175 |
| Vz/Fsema,50mg,ss apparent volume of distribution during elimination for semaglutide 50 mg at steady state | Measured in L | Day 140 to 175 |
| Vss/Fsema,50mg,ss apparent volume of distribution at steady state for semaglutide 50 mg | Measured in L | Day 140 to 175 |
| 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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