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

What Was Tested

This registered phase 1 trial tested Cagrilintide and Semaglutide.

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.

It had two arms (groups): Part A (other) and Part B (experimental).

Participants will not get any medicine during this study.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 164 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. A score of 7 or less on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire.

The full record lists 8 inclusion and 3 exclusion criteria; among the exclusions: contraindication for magnetic resonance scanning; history of type 1 or type 2 diabetes mellitus.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Cagrilintide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Cagrilintide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-02-15 with completion listed for 2025-04-07.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in mean postprandial appetite score based on visual analogue scale (VAS) (time frame: Baseline to week 24).

It also tracked 10 secondary outcomes, for example Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption, Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score, Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas, Relative change in total energy intake during ad libitum lunch, evening meal and snackbox, Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box and Change in total energy intake during ad libitum lunch, evening meal and snackbox.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 164 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cagrilintide compound page and the Semaglutide compound page, all human trials.