Clinical trial NCT06267092: A Study of How CagriSema Works on Appetite in People With Excess Body Weight
Official title: An Investigation of the Effect of Cagrilintide and Semaglutide Combination Treatment (CagriSema) on Appetite and Functional Brain Activity in People With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged 18-65 years (both inclusive) at the time of signing informed consent
* Right-handed as evaluated by the Edinburgh Handedness Inventory
* Body weight less than or equal to 180 kilogram at screening

For Part A:

* A score of 7 or less on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
* Body mass index between 18.5 and 24.9 kilogram per meter square (both inclusive) at screening

For Part B:

* A score of 8 or more on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
* Body mass index equal to or above 27.0 kilogram per meter square. Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion Criteria:

* Contraindication for magnetic resonance scanning

For Part B:

* Glycated haemoglobin greater than or equal to 6.5 % (48 millimoles per mole) at screening
* History of type 1 or type 2 diabetes mellitus

Primary outcomes:
measure: Change in mean postprandial appetite score based on visual analogue scale (VAS)
timeFrame: Baseline to week 24
Secondary outcomes:
measure: Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption
timeFrame: Baseline to week 24
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
timeFrame: Baseline pre-treatment ((Day 4 - Day 10) to treatment (Day 156 - Day 162))
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
timeFrame: Baseline to week 24
measure: Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score
timeFrame: Baseline to week 24
measure: Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas
timeFrame: Baseline to week 24
measure: Relative change in total energy intake during ad libitum lunch, evening meal and snackbox
timeFrame: Baseline to week 24
measure: Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box
timeFrame: Baseline to week 24
measure: Change in total energy intake during ad libitum lunch, evening meal and snackbox
timeFrame: Baseline to week 24
measure: Change in total amount of food consumed during ad libitum lunch, evening meal and snackbox
timeFrame: Baseline to week 24
measure: Change in body weight
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Office dept. 2834
role: STUDY_DIRECTOR
References: