A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity

Novo Nordisk

Status and phase: Enrolling; Phase 3

Conditions: Obesity

Treatments: Drug: Semaglutide; Drug: Placebo cagrilintide; Drug: Cagrilintide; Drug: Placebo semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06780449

U1111-1304-7430 (Other Identifier)

2024-512144-39 (Other Identifier)

NN9838-7859

Details and patient eligibility

About

This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.

Enrollment: 400 estimated 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.
• Body mass index (BMI) greater than or equal to (>=) 35.0 kilograms per meter square (kg/m^2).

Exclusion criteria

• Glycated haemoglobin (HbA1c) >= 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
• History of type 1 or type 2 diabetes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

CagriSema

Experimental group

Description:

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year.

Treatment:

Drug: Cagrilintide

Drug: Semaglutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year.

Treatment:

Drug: Placebo semaglutide

Drug: Placebo cagrilintide