Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)

What Was Tested

This registered phase 1 trial tested Cagrilintide and Semaglutide.

The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight.

Participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to treat people with type 2 diabetes and excess body weight) or placebo (a placebo looks like the treatment being tested but doesn't have any active ingredients in it).

Which treatment participants will get is decided by chance.

It had four arms (groups): CagriSema (experimental), Semaglutide (experimental), Cagrilintide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 50 years up to 70 years.

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

Examples of who could join: Male or female. Age 50-70 years (both inclusive) at the time of signing the informed consent. Body Mass index (BMI) between 30.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening (V1). Excess body weight should be due to excess adipose tissue, as judged by the investigator. Participant has a wish to lose at least 25 percentage (%) of body weight within 52 weeks of treatment.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: any leg amputations; female participants who are not postmenopausal at screening; treatment with any glucagon-like peptide-1 (glp-1) receptor agonist or a medication with glp-1 activity within 90 days before screening.

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.

The Cagrilintide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cagrilintide.

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

It started in 2026-04-10 with completion listed for 2028-04-28.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle (time frame: Baseline to Week 51).

It also tracked 2 secondary outcomes, for example Change in insulin-stimulated FDG uptake in skeletal muscle and Change in insulin-stimulated FDG uptake in skeletal muscle.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 100 people.

It is still 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, all human trials.