NCT06131437

A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

Efficacy and Safety of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15 mg s.c. Once-weekly in Participants With Obesity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 809 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Cagrilintide	Cagrilintide will be administered subcutaneously.
DRUG	Semaglutide	Semaglutide will be administered subcutaneously.
DRUG	Tirzepatide	Tirzepatide will be administered subcutaneously.

Timeline

• Start date: 2023-11-27
• Primary completion: 2025-12-08
• Completion: 2026-01-09
• First posted: 2023-11-14
• Last updated: 2026-02-06

Locations

46 sites across 1 country: United States

Regulatory

• FDA-regulated drug study