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Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema

Plain-language guide to NCT07817251: phase 3 randomized trial of Cagrilintide and Semaglutide, 210 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07817251
Phase
phase 3
Status
recruiting participants
Start
2026-09-16
Completion (planned or actual)
2027-06-09
Participants
210 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Diabetes Mellitus, Type 2
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.

The purpose of this clinical study is to look at the safety and tolerability of switching from semaglutide to CagriSema, for participants who have type 2 diabetes.

All participants will get CagriSema, the treatment being tested.

Participants will be in this clinical study for about 6 months.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

210 planned participants were the target.

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 7 inclusion and 6 exclusion criteria; among the exclusions: use of personal continuous glucose monitoring (cgm) devices. participants currently using personal cgm devices must discontinue use prior to screening and throughout study participation.

How the Study Was Run

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

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.

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 2026-09-16 with completion listed for 2027-06-09.

It ran at 40 sites in United States (40).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of treatment emergent adverse events (TEAEs) (time frame: From baseline (Week 0) to end of treatment (Week 16)).

It also tracked 7 secondary outcomes, for example Number of TEAEs, Number of TEAEs and Number of participants who discontinued due to gastrointestinal (GI) adverse events (AEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 210 people.

It is still recruiting; 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.