A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight

What Was Tested

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

The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight.

Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it.

Which treatment participants get is decided by chance.

It had three arms (groups): Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2 (experimental), Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 (experimental) and Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 (placebo comparator).

Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks.

Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.

Participants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.

The registry classes the interventions as drug.

Who Took Part

285 planned participants were the target.

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: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female (sex assigned at birth, inclusive of all gender identities). Age 18 years or above at the time of signing the informed consent.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: history of type 1 diabetes (t1d) or type 2 diabetes (t2d); treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.

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 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 2026-08-04 with completion listed for 2027-05-18.

It ran at 36 sites in United States (11), Greece (6), Portugal (6), Serbia (5), Hungary (4) and Sweden (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 26)).

It also tracked 2 secondary outcomes, for example Number of Treatment Emergent Adverse Events (TEAEs) and Number of Treatment Emergent Serious Adverse Events (TESAEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 285 people.

It is still 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, all human trials.