NCT06534411

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,023 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Cagrilintide	Participants will receive once-weekly cagrilintide subcutaneously.
DRUG	Semaglutide	Participants will receive once-weekly semaglutide subcutaneously.
DRUG	Tirzepatide	Participants will receive once-weekly tirzepatide subcutaneously.

Timeline

• Start date: 2024-11-05
• Primary completion: 2026-06-02
• Completion: 2026-07-14
• First posted: 2024-08-02
• Last updated: 2026-04-08

Locations

163 sites across 14 countries: United States, Argentina, Australia, Brazil, Canada, Germany, Greece, Hungary, India, Israel, Poland, Romania, Spain, Taiwan

Regulatory

• FDA-regulated drug study