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A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes

Plain-language guide to NCT07357740: phase 2 randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide). Who took part, design and what was measured.

Key Facts

Registry ID
NCT07357740
Phase
phase 2
Status
withdrawn
Start
2026-08-27
Completion (planned or actual)
2027-08-25
Participants
n/a (actual)
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

The trial (phase 2) is built around Cagrilintide and CagriSema (Cagrilintide + Semaglutide).

This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar.

Which treatment participants get is decided by chance.

It had two arms (groups): CagriSema in device 1 + Placebo CagriSema B in device 2 (experimental) and CagriSema B in device 2 + Placebo CagriSema in device 1 (experimental).

The registry classes the interventions as drug.

Who 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 (sex assigned at birth, inclusive of all gender identities). Age 18-64 years (both inclusive) at the time of signing the informed consent. Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. Glycated haemoglobin (HbA1c) 7.0-10.5 percent (%) (53-91 \[millimoles per mole\] mmol/mol) (both inclusive) as determined by the central laboratory at screening.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening; previous exposure to cagrisema in a clinical study.

How the Study Was Run

Design: 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.

Blinding on both sides kept the participants and researchers unaware of who received Cagrilintide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-08-27 with completion listed for 2027-08-25.

It ran at 61 sites in United States (21), Spain (11), Greece (6), Malaysia (5), Slovakia (5) and Thailand (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in glycated haemoglobin (HbA1c) (time frame: Baseline to week 28).

It also tracked 4 secondary outcomes, for example Change in HbA1c and Number of Treatment Emergent Adverse Events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cagrilintide and CagriSema (Cagrilintide + Semaglutide) in people.

It was withdrawn before enrolling anyone; 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.

Our Notes on the Compounds

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

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.