Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Cagrilintide and Semaglutide.

This study will look at how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (T2D).

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

Doctors may not yet prescribe CagriSema.

It had four arms (groups): CagriSema (experimental), Semaglutide (experimental), Cagrilintide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 158 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female. Aged 18-75 years (both inclusive) at the time of signing informed consent. Diagnosed with type 2 diabetes greater than or equal to (\>=) 180 days before screening. Body Mass index (BMI) between 25.0 and 45.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening.

The full record lists 6 inclusion and 4 exclusion criteria.

How the Study Was Run

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

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.

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

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 2024-05-06 with completion listed for 2025-12-28.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC) (time frame: Baseline to week 28).

It also tracked 25 secondary outcomes, for example To compare the effect of CagriSema versus semaglutide, Semaglutide versus placebo and Cagrilintide versus placebo: Change in M-value in HEC, Change in first-phase incremental insulin secretion rate (ISR0-8min) in hyperglycaemic clamp (HGC), Change in second-phase insulin secretion rate (ISR20-120min) in HGC, Change in total insulin secretion rate (ISR0-120min) in HGC, Change in insulin secretion rate at fixed glucose concentration (ISRg) in HGC and Change in total insulin response (total AUC0-120 min) in HGC.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 158 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.