Active Not Recruiting
PHASE3
INTERVENTIONAL
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
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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).
Interventions
Name:
Cagrilintide
Type:
DRUG
Description:
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.
Name:
Semaglutide
Type:
DRUG
Description:
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.
Name:
Placebo cagrilintide
Type:
DRUG
Description:
Participants will receive placebo matched to cagrilintide subcutaneously.
Name:
Placebo semaglutide
Type:
DRUG
Description:
Participants will receive placebo matched to semaglutide subcutaneously.
Primary Outcomes
Measure:
CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c)
TimeFrame:
From baseline (week 0) to end of treatment (week 68)
Description:
Measured in percentage-points.
Trial Information
NCT ID
NCT06065540
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025