NCT06221969

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 With or Without an SGLT2 Inhibitor

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (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 type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

Conditions

• Type 2 Diabetes

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: 2024-01-16
• Primary completion: 2026-03-04
• Completion: 2026-04-03
• First posted: 2024-01-24
• Last updated: 2026-04-08

Locations

196 sites across 8 countries: United States, Argentina, Australia, Canada, Colombia, India, South Africa, Taiwan

Regulatory

• FDA-regulated drug study