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

Novo Nordisk

Status and phase: Begins enrollment in 6 months; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo CagriSema; Drug: CagriSema

Study type: Interventional

Funder types: Industry

Identifiers

NCT07357740

2025-522570-37 (Other Identifier)

NN9388-8468

U1111-1323-3766 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups

CagriSema in device 1 + Placebo CagriSema B in device 2

Experimental group

Description:

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.

Treatment:

Drug: CagriSema

Drug: Placebo CagriSema

CagriSema B in device 2 + Placebo CagriSema in device 1

Experimental group

Description:

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.

Treatment:

Drug: CagriSema

Drug: Placebo CagriSema