A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

What Was Tested

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

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide.

The participants will receive one injection once a week.

The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 331 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.

The full record lists 7 inclusion and 5 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.

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 participants stayed in one arm throughout.

As a double-blind Cagrilintide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2023-04-03 with completion listed for 2025-01-17.

It ran at 28 sites in Japan (27) and Taiwan (1).

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 68)).

It also tracked 25 secondary outcomes, for example Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline, Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population, Change in VFA Measured by CT Scan in Subset of the Japanese Study Population, Relative Change in Body Weight, Change in Body Weight and Change in Body Mass Index (BMI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 331 people.

The trial is marked completed; 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.