A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity

What Was Tested

The trial (phase 3) is built around Cagrilintide and Semaglutide for fat loss, obesity & body recomposition.

This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine".

CagriSema cannot yet be prescribed by doctors.

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

Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 400 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: Male or female. Age above or equal to 18 years at the time of signing informed consent. Body mass index (BMI) greater than or equal to (\>=) 35.0 kilograms per meter square (kg/m\^2).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Cagrilintide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Cagrilintide.

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

It started in 2025-02-10 with completion listed for 2028-08-28.

It ran at 36 sites in United States (10), United Kingdom (7), Portugal (6), Denmark (5), Belgium (4) and Canada (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Relative change in body weight (time frame: From baseline (week 0) to week 104).

It also tracked 59 secondary outcomes, for example Change in waist circumference, Change in waist to height ratio, Change in Systolic Blood Pressure (SBP), Ratio to Baseline in Lipids: Total Cholesterol, Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol and Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 400 people with fat loss, obesity & body recomposition.

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.