Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

What Was Tested

This registered phase 3 trial tested Cagrilintide and CagriSema (Cagrilintide + Semaglutide) for fat loss, obesity & body recomposition.

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight.

Cagrilintide is a new investigational medicine.

Doctors may not yet prescribe cagrilintide.

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

Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.

Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.

The registry classes the interventions as drug.

Who Took Part

330 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. Female or male (sex at birth). Age 18 years or above at the time of signing the informed consent. History of at least one self-reported unsuccessful dietary effort to lose body weight.(a\*). Body mass index (BMI) \>= 27.0 kilogram per square meter (kg/m\^2).

The full record lists 11 inclusion and 3 exclusion criteria; among the exclusions: treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a\*).

How the Study Was Run

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

The fat loss, obesity & body recomposition 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 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 2025-11-05 with completion listed for 2027-05-12.

It ran at 67 sites in United States (21), Canada (9), South Korea (6), Romania (5), United Kingdom (5) and Croatia (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 64)).

It also tracked 28 secondary outcomes, for example Change in waist circumference, Ratio to baseline in lipids: triglycerides, Ratio to baseline in high sensitivity C-reactive protein (hsCRP), Change in glycated haemoglobin (HbA1c), Change in impact of weight on quality of life-lite clinical trials version (IWQOL-Lite-CT) physical function score and Change in systolic blood pressure (SBP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide) in 330 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 CagriSema (Cagrilintide + Semaglutide) compound page, Fat loss, obesity & body recomposition research.