A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

What Was Tested

The trial (phase 3) is built around Cagrilintide and Semaglutide.

This study has 2 parts: First part is the main study and second part is the extension study.

During the main study participants will receive 1 of 4 study medicines.

If participants continue in the extension study, they will not receive any study medicine during the extension.

It had four arms (groups): Cagrisema (experimental), Cagrilintide (active comparator), Semaglutide (active comparator) and Placebo s.c. (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

3400 planned participants were the target.

It was open to people of any sex.

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

Examples of who could join: Male or female. Age above or equal to 18 years at the time of signing informed consent.

The full record lists 3 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

As a double-blind Cagrilintide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2022-11-01 with completion listed for 2024-10-30.

It ran at 256 sites in United States (46), Poland (21), India (19), Bulgaria (17), Turkey (Türkiye) (16) and Japan (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: CagriSema versus placebo: Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 68)).

It also tracked 65 secondary outcomes, for example CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight, CagriSema versus placebo: Relative change in body weight, CagriSema versus placebo: Relative change in body weight, CagriSema versus placebo: Change in waist circumference, CagriSema versus placebo: Change in systolic blood pressure (SBP) and CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 3400 people.

With 3400 participants it is a large trial for this field.

Its status is active not recruiting; 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.