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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- withdrawn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.