A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor (REIMAGINE 2)

Novo Nordisk

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo cagrilintide; Drug: Placebo semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06065540

NN9388-4896

2022-502678-18 (EudraCT Number)

U1111-1283-0427 (Other Identifier)

Details and patient eligibility

About

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

Enrollment: 2,700 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) greater than or equal to 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 with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
• Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
• Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( 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

• Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by central laboratory at screening.
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,700 participants in 7 patient groups, including a placebo group

CagriSema 2.4 mg/2.4 mg

Experimental group

Description:

Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Treatment:

Drug: Semaglutide

Drug: Cagrilintide

CagriSema 1.0 mg/1.0 mg

Experimental group

Description:

Participants will receive once-weekly s.c injections of 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.

Treatment:

Drug: Semaglutide

Drug: Cagrilintide

Semaglutide 2.4 mg

Active Comparator group

Description:

Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 68 weeks.

Treatment:

Drug: Semaglutide

Semaglutide 1.0 mg

Active Comparator group

Description:

Participants will receive once-weekly s.c injection of 1.0 mg semaglutide for 68 weeks.

Treatment:

Drug: Semaglutide

Cagrilintide 2.4 mg

Active Comparator group

Description:

Participants will receive once-weekly s.c injection of 2.4 mg cagrilintide for 68 weeks.

Treatment:

Drug: Cagrilintide

Placebo 2.4 mg/2.4 mg

Placebo Comparator group

Description:

Participants will receive once-weekly s.c injection of placebo matched to 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Treatment:

Drug: Placebo semaglutide

Drug: Placebo cagrilintide

Placebo 1.0 mg/1.0 mg

Placebo Comparator group

Description:

Participants will receive once-weekly s.c injection of placebo matched to 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.

Treatment:

Drug: Placebo semaglutide

Drug: Placebo cagrilintide