A Research Study to See How Much CagriSema (1.0 mg Once Weekly) Lowers Blood Sugar and Body Weight Compared to Tirzepatide (5 mg Once Weekly) in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both (REIMAGINE 5)

Novo Nordisk

Status and phase: Enrolling; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Cagrilintide; Drug: Semaglutide; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06534411

NN9388-7741

2023-509600-15 (Other Identifier)

U1111-1300-2590 (Other Identifier)

Details and patient eligibility

About

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female.
• Age 18 years or above at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 180 days before screening.
• Stable daily dose(s) >= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
• Metformin
• sodium-glucose co-transporter 2 inhibitor (SGLT2i)
• Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
• Body mass index (BMI) >= 30 kilogram per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
• Renal impairment with estimated Glomerular Filtration Rate less than < 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by 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. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

CagriSema

Experimental group

Description:

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.

Treatment:

Drug: Semaglutide

Drug: Cagrilintide

Tirzepatide

Experimental group

Description:

Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks.

Treatment:

Drug: Tirzepatide