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.
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
Status
Completed
Phase
Phase 3
Enrollment
2,734
Locations
405
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Treatment arms and agents.
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
From registration to results.
First posted
Oct 4, 2023
Study start
Sep 27, 2023
Primary completion
Nov 19, 2025
Study completion
Jan 6, 2026
Results posted
Not reported
Registry updated
Jul 8, 2026
Outcomes
What the study measures.
Primary outcomes
CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage-points.
Secondary outcomes
CagriSema versus cagrilintide: Change in HbA1c
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage-points.
CagriSema versus cagrilintide: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage.
CagriSema (dose 1) versus semaglutide (dose 2): Change in HbA1c
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage-points.
CagriSema versus semaglutide: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage.
Cagrilintide versus placebo: Change in HbA1c
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage-points.
Cagrilintide versus placebo: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage.
CagriSema versus semaglutide: Achievement of greater than or equal to (>=) 10 percent (%) weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participants.
CagriSema versus semaglutide: Achievement of >= 15 % weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participants.
CagriSema versus semaglutide: Achievement of >= 20 % weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participants.
CagriSema (pooled doses) versus semaglutide (pooled doses): Continuous Glucose Monitoring (CGM) - Change in Time in Range (TIR) 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre [mg/dL])
Time frame · From baseline (week -3) to end of treatment (week 68)
Measured in percentage-points.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening. * Stable daily dose(s) greater than or equal to 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors. * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening. Exclusion Criteria: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by central laboratory at screening. * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation.
Study locations
405 registered 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. Showing up to 24 locations stored in the fast local snapshot.
Synexus Clin Res-Birmingham
Birmingham, Alabama, United States
Univ of Alabama_Birmingham
Birmingham, Alabama, United States
Cahaba Research
Pelham, Alabama, United States
Velocity Clinical Research-Phoenix
Phoenix, Arizona, United States
Synexus Rsch /Cnt Phnx Med C
Phoenix, Arizona, United States
Arkansas Clinical Research
Little Rock, Arkansas, United States
Velocity Clinical Res-Banning
Banning, California, United States
Velocity Clin Res-Chula Vista
Chula Vista, California, United States
John Muir Physicians Network
Concord, California, United States
Headlands Research California, LLC
Escondido, California, United States
Velocity Clin Res Gardena
Gardena, California, United States
Velocity Clin Res San Diego
La Mesa, California, United States
Loma Linda Univ Hlth Cr Endo
Loma Linda, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Velocity Clin Res- San Bern
San Bernardino, California, United States
Linda Vista Health Care Ctr
San Diego, California, United States
Velocity Clin Res Santa Ana
Santa Ana, California, United States
Premier Medical Center, Inc.
Toluca Lake, California, United States
Velocity Clin Res - Panorama
Van Nuys, California, United States
Optumcare Clinical Trials,LLC-Golden
Colorado Springs, Colorado, United States
Northeast Research Institute
Jacksonville, Florida, United States
Clinical Trial Services Corp
Miami, Florida, United States
Bioclinical Research Alliance
Miami, Florida, United States
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