The trial is taking place at:
R

Renstar Medical Research | Ocala, FL

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

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Novo Nordisk

Status and phase

Active, not recruiting
Phase 3

Conditions

Overweight
Type 2 Diabetes Mellitus
Obesity

Treatments

Drug: Cagrilintide
Drug: Placebo cagrilintide
Drug: Semaglutide
Drug: Placebo semaglutide

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

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

CagriSema
Experimental group
Description:
Cagrilintide + semaglutide once weekly
Treatment:
Drug: Semaglutide
Drug: Cagrilintide
Placebo
Placebo Comparator group
Description:
Placebo cagrilintide + semaglutide once weekly
Treatment:
Drug: Placebo semaglutide
Drug: Placebo cagrilintide

Trial contacts and locations

170

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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