A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight

Novo Nordisk

Status and phase: Begins enrollment in 4 months; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo CagriSema; Drug: Cagrisema

Study type: Interventional

Funder types: Industry

Identifiers

NCT07357766

NN9838-8166

2024-520448-41 (Other Identifier)

U1111-1317-0133 (Other Identifier)

Details and patient eligibility

About

This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female (sex at birth)
• Age 18 years or above at the time of signing the informing consent.
• Body Mass Index (BMI) is greater than or equal to (>= ) 30.0 kilograms per square metre (kg/m^2) or BMI >= 27.0 kg/m^2 with the presence of at least one obesity-related complication including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

Exclusion criteria

• Glycosylated haemoglobin (HbA1c) >= 6.5 % (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
• History of type 1 or type 2 diabetes.
• Previous exposure to CagriSema in a clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,400 participants in 3 patient groups, including a placebo group

CagriSema B in device 2 + Placebo in device 1

Experimental group

Description:

Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.

Treatment:

Drug: Cagrisema

CagriSema in device 1 + Placebo in device 2

Experimental group

Description:

Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.

Treatment:

Drug: Cagrisema

Placebo in device 1 + Placebo in device 2

Placebo Comparator group

Description:

Participants will receive placebo matched to Cagrisema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly for up to 44 weeks.

Treatment:

Drug: Placebo CagriSema