A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight (REDEFINE 2)

Novo Nordisk

Status and phase: Active, not recruiting; Phase 3

Conditions: Overweight; Type 2 Diabetes Mellitus; Obesity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05394519

2021-005121-24 (EudraCT Number)

U1111-1267-4287 (Other Identifier)

NN9838-4609

jRCT2031220671 (Registry Identifier)

Details and patient eligibility

About

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 planning to get pregnant during the study period.

Enrollment: 1,200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening

Exclusion criteria

• Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
• Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2, 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,200 participants in 2 patient groups, including a placebo group

CagriSema

Experimental group

Description:

Cagrilintide + semaglutide once weekly

Treatment:

Drug: Cagrilintide

Drug: Semaglutide

Placebo

Placebo Comparator group

Description:

Placebo cagrilintide + semaglutide once weekly

Treatment:

Drug: Placebo cagrilintide

Drug: Placebo semaglutide