A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

What Was Tested

In this phase 3 trial, researchers set out to test Cagrilintide and Semaglutide.

This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight.

CagriSema is a new investigational medicine.

Doctors may not yet prescribe CagriSema.

It had four arms (groups): one (active comparator), one (placebo comparator), one (active comparator) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

189 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 5 inclusion and 5 exclusion criteria.

How the Study Was Run

The set-up was 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 2024-03-19 with completion listed for 2025-10-01.

It ran at 50 sites in United States (21), Poland (7), China (5), Saudi Arabia (5), Hungary (4) and Italy (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 40)).

It also tracked 30 secondary outcomes, for example Relative change in body weight, Change in Fasting Plasma Glucose (FPG), Change in waist circumference, Change in systolic blood pressure (SBP), Change in diastolic blood pressure (DBP) and Ratio to baseline in high sensitivity C-reactive protein (hsCRP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 189 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.