A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet

What Was Tested

In this phase 1 trial, researchers set out to test Cagrilintide and Semaglutide for fat loss, obesity & body recomposition.

In this study the researchers will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet.

CagriSema is a new investigational medicine.

CagriSema cannot yet be prescribed by doctors but has previously been tested in humans.

It had two arms (groups): CagriSema (Cagrilintide + Semaglutide) / CagriSema (experimental) and Low Energy Diet (LED) / CagriSema (experimental).

The registry classes the interventions as behavioral and drug.

Who Took Part

80 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female (sex assigned at birth). Age 18-65 years (both inclusive) at the time of signing the informed consent.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: history of diabetes mellitus of any type, other than gestational diabetes mellitus; claustrophobia or severe discomfort of being confined in small rooms; unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Cagrilintide and who got the comparison, which limits bias.

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

Being open-label, the Cagrilintide study did not mask who received what.

It started in 2025-09-26 with completion listed for 2027-10-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in sleeping metabolic rate (SMR) (time frame: Baseline (Week 0) to Week 20).

It also tracked 3 secondary outcomes, for example Change in 24-hour energy expenditure, Change in resting metabolic rate (RMR) and Change in basal metabolic rate (BMR).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 80 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.