A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body

What Was Tested

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

The study is divided into two parts - Part A and Part B.

Cagrilintide in combination with semaglutide, is under development for weight management.

In the development of cagrilintide, it is important to see if liver function influences how the body absorbs, breaks down, and eliminates cagrilintide (Part A) and also how the medicine is absorbed and used by the body in healthy participants (Part B).

It had six arms (groups): Part A: Participants with normal hepatic function (experimental), Part A: Participants with mild hepatic impairment (experimental), Part A: Participants with moderate hepatic impairment (experimental), Part A: Participants with severe hepatic impairment (experimental) and Part B: Sequence 1 (experimental).

The registry classes the interventions as drug.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Male or female. Part A: Aged 18-80 years (both inclusive) at the time of signing informed consent. Part B: Aged 18-60 years (both inclusive) at the time of signing informed consent. Part A: Body mass index (BMI) between 18.5-39.9 kilograms per meter square (kg/m\^2) (both inclusive). Part B: BMI between 25-30 kg/m2 (both inclusive).

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Cagrilintide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Cagrilintide and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Cagrilintide study: the participants and staff both knew the treatment.

It started in 2023-04-05 with completion listed for 2024-09-06.

It ran at 4 sites in Slovakia (2), Czechia (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 14 secondary outcomes, for example Part B: AUC0-last,SD,cagri: The area under the cagrilintide plasma concentration-time curve from time 0 to last quantifiable observation and Part B: MRT SD,cagri: Mean residence time of cagrilintide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide) in 32 people.

Its size is small, so on its own it can only give an early look.

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.