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Part A: The study will look at participants appetite and energy intake and also look at the mechanisms of brain associated with appetite and food intake. Participants will not get any medicine and will be in a group that will be compared to another group receiving a weight-loss medicine. The study will last for about 6 months.
Part B: The study will look at how CagriSema works on participants appetite and energy intake and will be compared with a ''dummy'' medicine. The study will also look at how participants brain works when participants take the medicine. Participants will either get CagriSema or ''dummy'' medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Other | Participants will not get any medicine during this study. |
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| Part B | Experimental | Participants will receive CagriSema or placebo (Dose 1,2,3,4) for 16-weeks dose-escalation period followed by 37-weeks intervention period on CagriSema or placebo (Dose 5) that includes a 12-day standardised energy intake period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | Participants will not get any medicine during this study. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean postprandial appetite score based on visual analogue scale (VAS) | Measured in millimeter. 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 week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption | Measured in millimeter | Baseline to week 24 |
| Change in average DAILY EATS questionnaire scores over one week for: average hunger, worst hunger, appetite, cravings, satiety and eating drivers index composite score |
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Inclusion Criteria:
For Part A:
For Part B:
Exclusion Criteria:
For Part B:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Office dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Campus Charité Mitte - Charité Research Organisation GmbH | Berlin | 10117 | 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 |
| C000591245 | semaglutide |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Cagrilintide and Semaglutide |
| Drug |
Participants will receive subcutaneous (s.c.) injections of Cagrilintide and Semaglutide. |
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| Placebo | Drug | Participants will receive subcutaneous (s.c.) injections of placebo matched to Cagrilintide and Semaglutide. |
|
Measured in score points. The DAILY EATS is a 5-item, self-reported measure assessing key eating-related factors (Worst and Average Hunger, Appetite, Cravings, and Satiety). Additionally, an eating drivers index (EDI), comprising the related items Worst Hunger, Appetite, and Cravings can be calculated using this questionnaire. An 11-point numerical rating scale (0-10) is used for each item, with a higher value indicating more hunger, bigger appetite, stronger cravings, or greater satiety. |
| Baseline pre-treatment ((Day 4 - Day 10) to treatment (Day 156 - Day 162)) |
| Change in control of eating questionnaire (COEQ), 4 domains: craving control score, positive mood score, craving for sweets score and craving for savoury 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. | Baseline to week 24 |
| Change in power of food questionnaire for: food available score, food present score, food tasted score and 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"). | Baseline to week 24 |
| Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas | Measured in percentage | Baseline to week 24 |
| Relative change in total energy intake during ad libitum lunch, evening meal and snackbox | Measured in percentage | Baseline to week 24 |
| Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box | Measured in percentage point | Baseline to week 24 |
| Change in total energy intake during ad libitum lunch, evening meal and snackbox | Measured in kilojoules | Baseline to week 24 |
| Change in total amount of food consumed during ad libitum lunch, evening meal and snackbox | Measured in grams | Baseline to week 24 |
| Change in body weight | Measured in percentage | Baseline to week 24 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |