A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight

What Was Tested

This registered phase 1 trial tested Cagrilintide and Semaglutide.

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.

It had two arms (groups): CagriSema (experimental) and Placebo (active comparator).

Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once-weekly for 21 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 62 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. Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Body mass index (BMI) equal to or above 27.0 kilograms per meter square (kg/m\^2) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus; presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Cagrilintide and who got the comparison, which limits bias.

The Cagrilintide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cagrilintide.

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

It started in 2024-02-23 with completion listed for 2024-10-16.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Relative change in energy intake during ad libitum lunch, evening meal and snackbox (time frame: Baseline to Day 156).

It also tracked 22 secondary outcomes, for example Change in energy intake during ad libitum lunch, evening meal and snackbox, Change in amount of food consumed during ad libitum lunch, evening meal and snackbox, AUC0-5h,para, area under the paracetamol concentration-time curve from 0 to 5 hours after start of standardised meal, AUC0-1h,para, area under the paracetamol concentration-time curve from 0 to 1 hour after start of standardised meal, Cmax,para, maximum observed paracetamol concentration and tmax,para, time to maximum observed paracetamol concentration after start of standardised meal.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 62 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.