A Study of How CagriSema Works on Appetite in People With Excess Body Weight

Change in mean postprandial appetite score based on visual analogue scale (VAS)

Time frame · Baseline to week 24

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.

Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption

Time frame · Baseline to week 24

Measured in millimeter

Change in average DAILY EATS questionnaire scores over one week for: average hunger, worst hunger, appetite, cravings, satiety and eating drivers index composite score

Time frame · Baseline pre-treatment ((Day 4 - Day 10) to treatment (Day 156 - Day 162))

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.

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

Time frame · Baseline to week 24

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.

Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score

Time frame · Baseline to week 24

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").

Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas

Time frame · Baseline to week 24

Measured in percentage

Relative change in total energy intake during ad libitum lunch, evening meal and snackbox

Time frame · Baseline to week 24

Measured in percentage

Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box

Time frame · Baseline to week 24

Measured in percentage point

Change in total energy intake during ad libitum lunch, evening meal and snackbox

Time frame · Baseline to week 24

Measured in kilojoules

Change in total amount of food consumed during ad libitum lunch, evening meal and snackbox

Time frame · Baseline to week 24

Measured in grams

Change in body weight

Time frame · Baseline to week 24

Measured in percentage