A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

What Was Tested

This registered phase 3 trial tested Tirzepatide and Cagrilintide.

This study will look at how well 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 two arms (groups): CagriSema (experimental) and Tirzepatide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1024 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 (sex at birth). Age 18 years or above at the time of signing the informed consent. Diagnosed with type 2 diabetes ≥ 180 days before screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Tirzepatide study did not mask who received what.

It started in 2024-01-16 with completion listed for 2026-03-04.

It ran at 197 sites in United States (117), Canada (20), India (20), Australia (12), Argentina (10) and Taiwan (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 68)). Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 68)).

It also tracked 22 secondary outcomes, for example Change in HbA1c, Change in fasting plasma glucose (FPG), Change in systolic blood pressure, Change in diastolic blood pressure, Change in waist circumference and Ratio to baseline in lipids: Total cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Cagrilintide in 1024 people.

With 1024 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 Tirzepatide compound page and the Cagrilintide compound page, all human trials.