NCT06780449

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

Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Cagrilintide	Participants will receive cagrilintide subcutaneously.
DRUG	Semaglutide	Participants will receive semaglutide subcutaneously.
DRUG	Placebo cagrilintide	Participants will receive placebo matched to cagrilintide subcutaneously.
DRUG	Placebo semaglutide	Participants will receive placebo matched to semaglutide subcutaneously.

Timeline

• Start date: 2025-02-10
• Primary completion: 2028-08-28
• Completion: 2028-10-31
• First posted: 2025-01-17
• Last updated: 2026-01-20

Locations

36 sites across 6 countries: United States, Belgium, Canada, Denmark, Portugal, United Kingdom

Regulatory

• FDA-regulated drug study