NCT06323161

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes as Add on to Once-daily Basal Insulin With or Without Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (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 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 "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.

Conditions

• Type 2 Diabetes

Interventions

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

Timeline

• Start date: 2024-03-26
• Primary completion: 2025-09-09
• Completion: 2025-10-23
• First posted: 2024-03-21
• Last updated: 2025-11-28

Locations

53 sites across 6 countries: United States, China, Japan, Serbia, Slovakia, South Africa

Regulatory

• FDA-regulated drug study