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

NCTNCT07357740Other idNN9388-8468Other idU1111-1323-3766Other id2025-522570-37Other id2025

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: The study is withdrawn due to strategic reasons.

Overview

Status: Withdrawn
Phase: Phase 2
Enrollment: 0 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 8 countries
United States, Denmark, Greece, Malaysia, Serbia, Slovakia, Spain, Thailand
Start: 27 Aug 2026 (estimated)
Primary completion: 25 Aug 2027 (estimated)
Completion: 13 Oct 2027 (estimated)
First posted: 22 Jan 2026
Last update posted: 9 Jul 2026
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202620272028

Ph 2
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
NCT07357740
est. 27 Aug 2026 to est. 13 Oct 2027
Withdrawn
Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.

Interventions

CagriSemaDrug
Placebo CagriSemaDrug

Arms2

Experimental
CagriSema in device 1 + Placebo CagriSema B in device 2
Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner.
Experimental
CagriSema B in device 2 + Placebo CagriSema in device 1
Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in glycated haemoglobin (HbA1c)
Time frame · Baseline to week 28
Registry description
Measured as percentage-points (%-points).

Secondary outcomes(4)

Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses
Time frame · From baseline to week 28
Registry description
Measured in nanomoles per litre (nmol/L).
Change in HbA1c
Time frame · From baseline to week 28
Registry description
Measured as %-points.
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame · From baseline to week 35
Registry description
Measured as count of events.
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per litre [mmol/L]), confirmed by blood glucose (BG) meter, or severe hypoglycaemic episodes (level 3)
Time frame · From baseline to week 35
Registry description
Measured as count of episodes.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 64 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria * 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. * Stable daily dose \>= 90 days before screening of metformin at effective or maximum tolerated dose as judged by the investigator. * Body mass index (BMI) between 25.0 and 39.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening. Exclusion Criteria: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 millilitre per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by the central laboratory at screening. * Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. * Previous exposure to CagriSema in a clinical study.

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