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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1325-8810 | Other Identifier | World Health Organization (WHO) | |
| 2025-524206-15 | Other Identifier | European Medical Agency (EMA) |
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The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cagrilintide | Experimental | Participant will receive Cagrilintide subcutaneously once weekly for up to 17 weeks. |
|
| Placebo Cagrilintide | Placebo Comparator | Participant will receive placebo matched to Cagrilintide subcutaneously once weekly for up to 17 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Cagrilintide is administered subcutaneously . |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box | Measured in percentage (%). | From baseline (Day 2) to end of treatment (Day 127) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box | Measured in kilojoule (kJ). | From baseline (Day 2) to end of treatment (Day 127) |
| Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box |
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Inclusion Criteria:
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 |
|---|---|
| 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 |
|---|---|
| C000717792 | cagrilintide |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo Cagrilintide |
| Drug |
Placebo Cagrilintide is administered subcutaneously. |
|
Measured in grams (g). |
| From baseline (Day 2) to end of treatment (Day 127) |
| Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box | Measured in kJ. | From baseline (Day 2) to end of treatment (Day 127) |
| Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS) | Measured in millimetre(mm). VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as [hunger + (100 - satiety) + (100 - fullness) + prospective food consumption]/4. Scores of 0 mm are worst and scores of 100 mm are best. | From baseline (Day 1) to end of treatment (Day 126) |
| Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption | Measured in mm. VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as [hunger + (100 - satiety) + (100 - fullness) + prospective food consumption]/4. Scores of 0 mm are worst and scores of 100 mm are best. | From baseline (Day 1) to end of treatment (Day 126) |
| Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness | Measured in mm. VAS appeal questions record the participant's sensations within taste, visual appearance and overall pleasantness by the participants on a paper printed scale line from 0 to 100 mm. Scores of 0 mm are worst and scores of 100 mm are best. | From baseline (Day 1) to end of treatment (Day 126) |
| Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS | Measured in mm. VAS appetite questions record the participant's sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as [hunger + (100 - satiety) + (100 - fullness) + prospective food consumption]/4. Scores of 0 mm are worst and scores of 100 mm are best. | From baseline (Day 1) to end of treatment (Day 126) |
| • Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score | Measured in score points. The COEQ is a self-reported measure assessing various aspects of eating behaviour and related psychological factors. The COEQ has 19 different questions designed to assess the intensity and type of food cravings, as well as subjective sensations of appetite and mood. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control (0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); Higher score represents a greater level of Craving Control. | From baseline (Day -1) to end of treatment (Day 125) |
| Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score | Measured in score points. The power of food questionnaire measures three factors that correspond to different levels of food proximity and reflect responsiveness to food-abundant environments: food available (food that is available, but not physically present), food present (food that is present, but not tasted), and food tasted (food that is tasted, but not consumed). Moreover, an aggregate score is calculated as the mean of the three subdomains. The questionnaire consists of 15 questions, and the participants will be asked to rate their agreement or disagreement with each statement on a 5-point scale (ranging from "strongly disagree" to "strongly agree"). | From baseline (Day -1) to end of treatment (Day 125) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |