A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight (REDEFINE 6)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Obesity or Overweight

Treatments: Drug: Semaglutide; Drug: Placebo Cagrilintide; Drug: Placebo Semaglutide; Drug: Cagrilintide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05996848

U1111-1267-4364 (Other Identifier)

NN9838-4827

Details and patient eligibility

About

This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.

Enrollment: 300 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

  1. Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or
  2. BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:

• Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening
• Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) 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 60 days before screening
• Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at screening

Exclusion criteria

For participants without T2D at screening:

• HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
• History of type 1 or type 2 diabetes mellitus

For participants with T2D at screening:

• Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
• Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (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: Double Blind

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300 participants in 3 patient groups, including a placebo group

CagriSema

Experimental group

Description:

Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.

Treatment:

Drug: Cagrilintide

Drug: Semaglutide

Semaglutide

Active Comparator group

Description:

Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.

Treatment:

Drug: Placebo Semaglutide

Drug: Semaglutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.

Treatment:

Drug: Placebo Semaglutide

Drug: Placebo Cagrilintide