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NCT06065540Recruiting

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
Novo Nordisk A/SPhase 3ClinicalTrials.govdrug
Study focus
Drug/Device/Intervention
Cagrilintide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Novo Nordisk A/S
Location
Birmingham,Birmingham,Pelham,Phoenix,Phoenix,Little Rock,Banning,Chula Vista,Concord,Escondido,Gardena,La Mesa,La Mesa,Loma Linda,Mission Hills,Palm Springs,Panorama City,San Diego,Santa Ana,Toluca La, Argentina,Australia,Brazil,Bulgaria,Canada,China,Colombia,Croatia,Czech,Denmark,Finland,Germany,Gree
Timeline & enrollment
Phase
Phase 3
Start date
Sep 27, 2023
End date
Jan 14, 2026
Enrollment
2700 participants
Primary outcome

CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Change in glycated haemoglobin (HbA1c),CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Relative change in body weight

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).

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06065540
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06065540 through Pure Global AI's free database. This Phase 3 trial is sponsored by Novo Nordisk A/S and is currently Recruiting. The study focuses on Type 2 Diabetes Mellitus. Target enrollment is 2700 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.