Clinical trial

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

Active, not recruiting · Phase 3 · 6 countries · Registry ID NCT06780449

Active, not recruitingPhase 3Interventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

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.

Treatments and study arms

Cagrilintide

Drug

Participants will receive cagrilintide subcutaneously.

Semaglutide

Drug

Participants will receive semaglutide subcutaneously.

Placebo cagrilintide

Drug

Participants will receive placebo matched to cagrilintide subcutaneously.

Placebo semaglutide

Drug

Participants will receive placebo matched to semaglutide subcutaneously.

Primary outcomes

Relative change in body weightFrom baseline (week 0) to week 104

Measured in percentage (%).

Study locations

36 locations were listed when this page was built. The first 40 are shown.

Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie🇧🇪 Brussels, Belgium