A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants

What Was Tested

In this phase 1 trial, researchers set out to test Cagrilintide and CagriSema (Cagrilintide + Semaglutide).

The study tests if treatment with cagrilintide delays the transmission of electrical signals in the heart compared to treatment with placebo.

To confirm the sensitivity of the methodology, the drug moxifloxacin is also compared to a placebo in 2 treatment arms.

Cagrilintide is being developed for the treatment of obesity and weight management.

It had three arms (groups): Cagrilintide (Arm 1) (experimental), Cagrilintide Placebo (Arm 2A) (active comparator) and Cagrilintide Placebo (Arm 2B) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 107 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female. Aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 23.0 and 29.9 kilogram per meter\^2 (kg/m\^2) (both inclusive) at screening.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products, or to electrocardiogram (ecg) electrodes.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

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 2023-04-12 with completion listed for 2023-08-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide) in 107 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 CagriSema (Cagrilintide + Semaglutide) compound page, all human trials.