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A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity

Plain-language guide to NCT06716307: phase 1 randomized trial of Cagrilintide and Semaglutide, 18 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06716307
Phase
phase 1
Status
completed
Start
2024-12-02
Completion (planned or actual)
2025-03-28
Participants
18 (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.

CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide.

It is still being tested in studies and is not yet available for doctors to prescribe.

It had two arms (groups): Treatment sequence 1 (experimental) and Treatment sequence 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female. Aged 18-64 years (both inclusive) at the time of signing informed consent. Body Mass Index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.

How the Study Was Run

It was run as a randomized, crossover and open-label 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.

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

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

It started in 2024-12-02 with completion listed for 2025-03-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Number of adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Cagrilintide and Semaglutide in 18 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.

Related Pages

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.