The trial is taking place at:
O

Oviedo Medical Research | Oviedo, 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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