A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Obesity or Overweight

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05813925

jRCT2031220734 (Registry Identifier)

NN9838-4762

U1111-1277-3764 (Other Identifier)

Details and patient eligibility

About

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Age greater than to or equal 18 years at the time of signing informed consent
• a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D

Diabetes-related for participant with T2D

• Diagnosed with T2D greater than or equal to 180 days before screening
• HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at 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 cotransporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] 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

Exclusion criteria

Obesity-related

• Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening

Glycaemia-related for participant without T2D

• 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

Diabetes-related for participant with T2D

• 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 central laboratory at screening
• Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness
• 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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331 participants in 2 patient groups

CagriSema 2.4 mg/2.4 mg

Experimental group

Description:

Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly (OW) after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks

Treatment:

Drug: Cagrilintide

Drug: Semaglutide

Semaglutide 2.4 mg

Active Comparator group

Description:

Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks

Treatment:

Drug: Placebo Semaglutide

Drug: Semaglutide