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, SGLT2 Inhibitor or Both

Plain-language guide to NCT06534411: phase 3 randomized trial of Tirzepatide and Cagrilintide, 1023 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06534411
Phase: phase 3
Status: completed
Start: 2024-11-05
Completion (planned or actual): 2026-06-02
Participants: 1023 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes Mellitus, Type 2
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

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

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes.

CagriSema is a new investigational medicine.

Doctors cannot yet prescribe CagriSema.

It had two arms (groups): CagriSema (experimental) and Tirzepatide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1023 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 8 inclusion and 4 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

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

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-11-05 with completion listed for 2026-06-02.

It ran at 163 sites in United States (54), Canada (13), India (13), Hungary (10), Taiwan (10) and Poland (9).

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 60)). Relative Change in Body Weight (time frame: From baseline (week 0) to end of treatment (week 60)).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Cagrilintide in 1023 people.

With 1023 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.

Our Notes on the Compounds

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Cagrilintide: An investigational long-acting amylin analog; CagriSema combines it with semaglutide.

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.