A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

What Was Tested

This registered phase 3 trial tested Cagrilintide and Semaglutide.

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight.

Participants will either get CagriSema or a dummy medicine.

Which treatment they get is decided by chance.

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

Cagrilintide + semaglutide once weekly.

Placebo cagrilintide + semaglutide once weekly.

The registry classes the interventions as drug.

Who Took Part

1200 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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. BMI greather than or equal to 27.0 kg/m\^2. Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.

The full record lists 7 inclusion and 3 exclusion criteria.

How the Study Was Run

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

Because people in this Cagrilintide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2023-02-01 with completion listed for 2025-01-28.

It ran at 179 sites in United States (49), India (20), Poland (20), United Kingdom (17), Canada (13) and Germany (10).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 34 secondary outcomes, for example Relative change in body weight, Change in waist circumference, Change in Glycated Haemoglobin (HbA1c), Change in Systolic Blood Pressure (SBP), Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score and Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 1200 people.

With 1200 participants it is a large trial for this field.

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.