A Research Study to See How Well CagriSema Helps People Losing Weight in People Who Have a Body Weight Above the Healthy Range and Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2024-10-28
• Target enrollment: 0
• Participant gender: All

Summary

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance.

The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Male or female

• Age above or equal to 18 years at the time of signing informed consent

• BMI greather than or equal to 27.0 kg/m^2

• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening

• Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label

• Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening

• HbA1c below or equal to 10% (86 mmol/mol) as measured by the central laboratory at screening

Exclusion Criteria:

• Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2 (below 45 mL/min/1.73 m^2 in participants treated with SGLT2i), as measured by the central laboratory at screening

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination