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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1286-0585 | Other Identifier | World Health Organization (WHO) | |
| 2023-504792-24-00 | Other Identifier | European Medical Agency (EMA) |
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This research study tests if CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight. Participant will either get CagriSema (active medicine) or placebo (a dummy medicine), which has no effect on the body. The treatment participants get is decided by chance. The study will last for about 32 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema | Experimental | Participants will receive dose 1 cagrilintide and dose 2 semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) during the maintenance period of 5 weeks. |
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| Placebo | Active Comparator | Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once-weekly for 21 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Cagrilintide will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in energy intake during ad libitum lunch, evening meal and snackbox | Measured in percentage (%). | Baseline to Day 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in energy intake during ad libitum lunch, evening meal and snackbox | Measured in kilojoule (KJ). | Baseline to Day 156 |
| Change in amount of food consumed during ad libitum lunch, evening meal and snackbox |
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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 |
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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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
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| Semaglutide |
| Drug |
Semaglutide will be administered subcutaneously. |
|
| Placebo | Drug | Placebo will be administered subcutaneously. |
|
Measured in grams (g).
| Baseline to Day 156 |
| AUC0-5h,para, area under the paracetamol concentration-time curve from 0 to 5 hours after start of standardised meal | Measured in hour*milligram per milliliter ( h*mg/mL). | Day 1 and Day 155: 0-5 hour after standardised meal |
| AUC0-1h,para, area under the paracetamol concentration-time curve from 0 to 1 hour after start of standardised meal | Measured in h*mg/mL. | Day 1 and Day 155: 0-1 hour after standardised meal |
| Cmax,para, maximum observed paracetamol concentration | Measured in microgram per milliliter (µcg/mL). | Day 1 and Day 155: 0-5 hour after standardised meal |
| tmax,para, time to maximum observed paracetamol concentration after start of standardised meal | Measured in hours (h). | Day 1 and Day 155: 0-5 hour after standardised meal |
| Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box | Measured in %-point. | Baseline to Day 156 |
| Change in Control of Eating questionnaire (COEQ): Craving Control score | The Control of Eating Questionnaire (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. | Baseline to Day 154 |
| Change in COEQ: Positive Mood score | 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. | Baseline to Day 154 |
| Change in COEQ: Craving for Sweets score | 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. | Baseline to Day 154 |
| Change in COEQ: Craving for Savoury food score | 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. | Baseline to Day 154 |
| Change in mean postprandial Visual Analogue Scale (VAS) ratings of Hunger | Measured in millimeter (mm). VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness, 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. | Baseline to Day 156 |
| Change in mean postprandial VAS ratings of Fullness | 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. | Baseline to Day 156 |
| Change in mean postprandial VAS ratings of Satiety | 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. | Baseline to Day 156 |
| Change in mean postprandial VAS ratings of 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. | Baseline to Day 156 |
| Change in mean postprandial VAS ratings of Appetite Score | 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. | Baseline to Day 156 |
| Change in Power of Food questionnaire for Food available score | 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"). | Baseline to Day 155 |
| Change in Power of Food questionnaire for Food present score | 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"). | Baseline to Day 155 |
| Change in Power of Food questionnaire for Food tasted score | 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"). | Baseline to Day 155 |
| Change in Power of Food questionnaire for Composite score | 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"). | Baseline to Day 155 |
| Change in mean score from the Monetary Choice Questionnaire | The 27-item version of the Monetary Choice Questionnaire63 is used to assess participants' individual preference for immediate versus delayed monetary rewards. The questions comprise hypothetical choices between smaller immediate rewards or larger delayed rewards. The specific amounts and delays of the rewards vary across questions. For each question, the participant is asked to choose which option they would prefer. The responses are used to calculate a measure of participants' willingness to delay gratification and their discount rate (k) for delayed rewards. | Baseline to Day 157 |
| Change in body weight | Measured in %. | Baseline to Day 155 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |