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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Cagrilintide will be administered subcutaneously.
Semaglutide will be administered subcutaneously.
Placebo will be administered subcutaneously.
Parexel International GmbH
Berlin, Germany
Relative change in energy intake during ad libitum lunch, evening meal and snackbox
Measured in percentage (%).
Time frame: Baseline to Day 156
Change in energy intake during ad libitum lunch, evening meal and snackbox
Measured in kilojoule (KJ).
Time frame: Baseline to Day 156
Change in amount of food consumed during ad libitum lunch, evening meal and snackbox
Measured in grams (g).
Time frame: 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).
Time frame: 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.
Time frame: Day 1 and Day 155: 0-1 hour after standardised meal
Cmax,para, maximum observed paracetamol concentration
Measured in microgram per milliliter (µcg/mL).
Time frame: 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).
Time frame: Day 1 and Day 155: 0-5 hour after standardised meal
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Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box
Measured in %-point.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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.
Time frame: Baseline to Day 157
Change in body weight
Measured in %.
Time frame: Baseline to Day 155