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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1319-9246 | Other Identifier | World Health Organization (WHO) | |
| 2025-521393-34 | Other Identifier | European Medicines Agency (EMA) |
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The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants will get is decided by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 | Experimental | Participants will be randomized to receive 1 of the different dose levels of NNC0487-0111 subcutaneously once weekly. |
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| Placebo | Placebo Comparator | Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126 | Measured as percentage change of energy. | From Baseline to Day 126 |
| Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182 | Measured as percentage change of energy. | From Baseline to Day 182 |
| Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238 | Measured as percentage change of energy. | From Baseline to Day 238 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126 | Measured as kilojoules (kJ). | From Baseline to Day 126 |
| Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182 |
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Key Inclusion Criteria:
Key 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 |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Recruiting | Berlin | 14050 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (matched to NNC0487-0111) | Drug | Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen. |
|
Measured as kJ. |
| From Baseline to Day 182 |
| Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238 | Measured as kJ. | From Baseline to Day 238 |
| Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 126 | Measured as grams. | From Baseline to Day 126 |
| Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 182 | Measured as grams. | From Baseline to Day 182 |
| Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 238 | Measured as grams. | From Baseline to Day 238 |
| Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 378 | Measured as percentage change of energy. | From Baseline to Day 378 |
| Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box at Day 378 | Measured as kJ. | From Baseline to Day 378 |
| Change from baseline in total amount of food consumed during ad libitum breakfast, lunch, evening meal and snack box to Day 378 | Measured as grams. | From Baseline to Day 378 |
| Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 126 | Measured as kJ. | From Baseline to Day 126 |
| Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 182 | Measured as kJ. | From Baseline to Day 182 |
| Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 238 | Measured as kJ. | From Baseline to Day 238 |
| Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 378 | Measured as kJ. | From Baseline to Day 378 |
| Relative change from Day 19 in body weight to Day 131 | Measured as percentage change of body weight. | From Day 19 to Day 131 |
| Relative change from Day 19 in body weight to Day 187 | Measured as percentage change of body weight. | From Day 19 to Day 187 |
| Relative change from Day 19 in body weight to Day 243 | Measured as percentage change of body weight. | From Day 19 to Day 243 |
| Relative change from Day 19 in body weight to Day 383 | Measured as percentage change of body weight. | From Day 19 to Day 383 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |