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

NCT06065540 · Completed

Last updated 2026-05-28

This study is testing how well the experimental drug CagriSema works compared to semaglutide, cagrilintide, and a placebo to lower blood sugar and body weight in adults with type 2 diabetes who are already taking metformin, with or without another diabetes medication.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 2,734 people

Who can join Ages 18+ · all sexes

Timeline Started 2023-09 · est. completion 2026-01

Where 405 sites · 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, United States

What this study is testing ClinicalTrials.gov NCT06065540 ↗

Description as written by the study sponsor.

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).

Treatments tested

Cagrilintide Drug

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.
Semaglutide Drug

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.
Placebo cagrilintide Drug

Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutide Drug

Participants will receive placebo matched to semaglutide subcutaneously.

Main thing measured	CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c)
Sponsor	Novo Nordisk A/S
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	semaglutide, cagrilintide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06065540 ↗