A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight

Plain-language guide to NCT05996848: phase 3 randomized trial of Cagrilintide and Semaglutide, 300 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05996848
Phase: phase 3
Status: completed
Start: 2023-08-15
Completion (planned or actual): 2025-01-06
Participants: 300 (actual)
Design: randomized, double-blind, treatment
Conditions studied: Obesity or Overweight
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Cagrilintide and Semaglutide.

This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide.

Participants will either get CagriSema, a dummy medicine or semaglutide.

Which treatment participants get is decided by chance.

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

Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.

The registry classes the interventions as drug.

Who Took Part

300 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus.

How the Study Was Run

Design: randomized, parallel-group and double-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 and investigator.

It started in 2023-08-15 with completion listed for 2025-01-06.

It ran at 37 sites in China (37).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: CagriSema [amount hidden] versus placebo: Relative change in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 300 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 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.