protocolSection identificationModule nctId: NCT06267092, orgStudyIdInfo id: NN9838-4944, briefTitle: A Study of How CagriSema Works on Appetite in People With Excess Body Weight, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-01-19, completionDateStruct date: 2026-01-19, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Overweight, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: No treatment given, interventions name: Cagrilintide and Semaglutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in mean postprandial appetite score based on visual analogue scale (VAS), secondaryOutcomes measure: Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption, secondaryOutcomes measure: Change in average DAILY EATS questionnaire scores over one week for: average hunger, worst hunger, appetite, cravings, satiety and eating drivers index composite score, secondaryOutcomes measure: 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, secondaryOutcomes measure: Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score, secondaryOutcomes measure: Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas, secondaryOutcomes measure: Relative change in total energy intake during ad libitum lunch, evening meal and snackbox, secondaryOutcomes measure: Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box, secondaryOutcomes measure: Change in total energy intake during ad libitum lunch, evening meal and snackbox, secondaryOutcomes measure: Change in total amount of food consumed during ad libitum lunch, evening meal and snackbox, secondaryOutcomes measure: Change in body weight, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité Research Organisation GmbH, status: RECRUITING, city: Berlin, zip: 10117, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False