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 Once-daily Basal Insulin With or Without Metformin

What Was Tested

This registered phase 3 trial tested Cagrilintide and Semaglutide.

This study will look at how much CagriSema helps people 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 (active comparator), one (placebo comparator) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 274 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 6 exclusion criteria; among the exclusions: treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening; known hypoglycaemia unawareness as indicated by the investigator according to clarke's questionnaire question 8; recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Cagrilintide.

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

It started in 2024-03-26 with completion listed for 2025-09-09.

It ran at 61 sites in United States (18), Japan (16), China (9), South Africa (8), Serbia (5) and Slovakia (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycated Haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 40)).

It also tracked 31 secondary outcomes, for example Relative Change in Body Weight, Change in Fasting Plasma Glucose (FPG), Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals), Change in Waist Circumference, Change in Systolic Blood Pressure (SBP) and Change in Diastolic Blood Pressure (DBP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 274 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.