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A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

Plain-language guide to NCT06131437: phase 3 randomized trial of Tirzepatide and Cagrilintide, 809 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06131437
Phase
phase 3
Status
completed
Start
2023-11-27
Completion (planned or actual)
2025-12-08
Participants
809 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight.

CagriSema is not yet being prescribed by doctors.

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 809 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. Age 18 years or above at the time of signing the informed consent. Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m\^2).

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

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

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

It started in 2023-11-27 with completion listed for 2025-12-08.

It ran at 46 sites in United States (46).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 14 secondary outcomes, for example Change in waist circumference, Change in systolic blood pressure (SBP), Change in diastolic blood pressure (DBP), Relative change in lipids: Total cholesterol, Relative change in lipids: High-density lipoprotein (HDL) cholesterol and Relative change in lipids: Non-HDL cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Cagrilintide in 809 people.

With 809 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).

Related Pages

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.