A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

What Was Tested

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

The study will look at how well CagriSema helps people lower their blood sugar and body weight.

CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide.

CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone.

It had seven arms (groups): one (experimental), one (experimental), one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 2734 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.

The full record lists 6 inclusion and 3 exclusion criteria.

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.

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 2023-09-27 with completion listed for 2025-11-19.

It ran at 405 sites in United States (100), Canada (31), Poland (20), Turkey (Türkiye) (20), Germany (15) and India (15).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 37 secondary outcomes, for example CagriSema versus cagrilintide: Change in HbA1c, CagriSema versus cagrilintide: Relative change in body weight, CagriSema versus semaglutide: Relative change in body weight, Cagrilintide versus placebo: Change in HbA1c, Cagrilintide versus placebo: Relative change in body weight and CagriSema versus semaglutide: Change in Systolic Blood Pressure (SBP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 2734 people.

With 2734 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.