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

Novo Nordisk A/S164 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

164

Conditions

Overweight Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.