A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight

Plain-language guide to NCT06289504: phase 1 randomized trial of Cagrilintide and Semaglutide, 34 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06289504
Phase: phase 1
Status: completed
Start: 2024-02-27
Completion (planned or actual): 2024-10-16
Participants: 34 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Obesity
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 1 trial, researchers set out to test Cagrilintide and Semaglutide.

This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin.

The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema.

The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood.

It had 1 arm (groups): CagriSema +Atorvastatin + Warfarin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 34 actual participants took part.

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. Aged 18-65 years (both inclusive) at the time of signing informed consent. Body Mass Index (BMI) between 27.0 and 39.9 kilograms per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

The full record lists 3 inclusion and 7 exclusion criteria.

How the Study Was Run

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

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

Everyone knew when Cagrilintide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-02-27 with completion listed for 2024-10-16.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 21 secondary outcomes, for example Cmax, cagri, SS: Maximum observed cagrilintide plasma concentration at steady state, tmax, cagri, SS: Time to maximum observed cagrilintide plasma concentration at steady state, Cmax, sema,SS: Maximum observed semaglutide plasma concentration at steady state, tmax, sema, SS: Time to maximum observed semaglutide plasma concentration at steady state, CL/Fcagri,SS: total apparent clearance of cagrilintide at steady state and CL/Fsema,SS: total apparent clearance of semaglutide at steady state.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 34 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 Semaglutide compound page, all human trials.

Our Notes on the Compounds

Cagrilintide: An investigational long-acting amylin analog; CagriSema combines it with semaglutide.

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

CagriSema (Cagrilintide + Semaglutide): A once-weekly fixed combination of cagrilintide (amylin analog) and semaglutide (GLP-1) tested in the phase 3 REDEFINE program.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.