NCT06065540

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight 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) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,734 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Cagrilintide	Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose 1 and dose 2 of cagrilintide is reached.
DRUG	Semaglutide	Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose 1 and dose 2 of semaglutide is reached.
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: 2023-09-27
• Primary completion: 2025-11-19
• Completion: 2026-01-06
• First posted: 2023-10-04
• Last updated: 2026-01-22

Locations

405 sites across 32 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czechia, Denmark, Finland, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Romania, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study