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

What Was Tested

The trial (phase 3) is built around Cagrilintide and CagriSema (Cagrilintide + Semaglutide).

This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight.

CagriSema is still being tested in studies and is not yet available for doctors to prescribe.

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

Participants will receive placebo matched to Cagrisema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly for up to 44 weeks.

The registry classes the interventions as drug.

Who 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 informing consent.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes; previous exposure to cagrisema in a clinical study.

How the Study Was Run

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

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

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 2026-06-22 with completion listed for 2027-11-29.

It ran at 116 sites in United States (26), Bulgaria (13), Malaysia (11), Poland (11), Greece (7) and Romania (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 44)).

It also tracked 2 secondary outcomes, for example Number of TEAEs (treatment emergent adverse events) and Number of TESAEs (Treatment emergent serious adverse events).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cagrilintide compound page and the CagriSema (Cagrilintide + Semaglutide) compound page, all human trials.