A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

What Was Tested

In this phase 3 trial, researchers set out to test Cagrilintide and Semaglutide for fat loss, obesity & body recomposition.

This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term.

The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'.

In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient).

It had two arms (groups): CagriSema (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

609 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. BMI ≥ 30.0 kilogram per square meter (kg/m\^2) at screening.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

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

Neither the fat loss, obesity & body recomposition participants nor the staff measuring them knew who was on Cagrilintide, so expectations could not easily colour the readings.

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

It started in 2025-06-03 with completion listed for 2027-03-01.

It ran at 47 sites in United States (47).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Relative change in body weight (time frame: From baseline (week 0) to week 80).

It also tracked 40 secondary outcomes, for example Relative change in body weight in women, Number of participants who achieve BMI < 30 kg/m^2, Change in waist circumference, Change in systolic blood pressure, Ratio to baseline in C-reactive protein (CRP) and Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 609 people with fat loss, obesity & body recomposition.

With 609 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cagrilintide compound page and the Semaglutide compound page, Fat loss, obesity & body recomposition research.