DRUG
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Status
Completed
Phase
Phase 3
Enrollment
1,023
Locations
163
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
DRUG
Tirzepatide
Participants will receive once-weekly tirzepatide subcutaneously.
Timeline
From registration to results.
First posted
Aug 2, 2024
Study start
Nov 5, 2024
Primary completion
Jun 2, 2026
Study completion
Jul 9, 2026
Results posted
Not reported
Registry updated
Jul 17, 2026
Outcomes
What the study measures.
Primary outcomes
Change in Glycated Haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured in percentage points.
Relative Change in Body Weight
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured in percentage (%).
Secondary outcomes
Change in HbA1c
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured in percentage points.
Change in Fasting Plasma Glucose (FPG)
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured as millimole per liter (mmol/L).
Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol])
Time frame · At end of treatment (week 60)
Measured as count of participants.
Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol)
Time frame · At end of treatment (week 60)
Measured as count of participants.
Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured as count of participants.
Number of Participants Who Achieve >= 10% Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured as count of participants.
Number of Participants Who Achieve >= 15% Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured as count of participants.
Number of Participants Who Achieve >= 20% Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured as count of participants.
Change in Systolic Blood Pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured in millimeter of mercury (mmHg).
Change in Diastolic Blood Pressure (DBP)
Time frame · From baseline (week 0) to end of treatment (week 60)
Measured in mmHg.
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) \>= 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 * sodium-glucose co-transporter 2 inhibitor (SGLT2i) * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) \>= 30 kilogram per square meter (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: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening. * Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is 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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Study locations
163 registered sites.
Argentina · Australia · Brazil · Canada · Germany · Greece · Hungary · India · Israel · Poland · Romania · Spain · Taiwan · United States. Showing up to 24 locations stored in the fast local snapshot.
Cahaba Research
Pelham, Alabama, United States
Velocity Clinical Research-Phoenix
Phoenix, Arizona, United States
AES Tucson DRS
Tucson, Arizona, United States
Woodland Int. Research Group
Little Rock, Arkansas, United States
Velocity Clin Res-Chula Vista
Chula Vista, California, United States
John Muir Physicians Network
Concord, California, United States
Diabetes & Endocrine Specialists - La Mesa
La Mesa, California, United States
Velocity Clin Research LA
Los Angeles, California, United States
Desert Oasis Healthcare
Palm Springs, California, United States
Velocity Clin Res Santa Ana
Santa Ana, California, United States
Velocity Clin Res - Panorama
Van Nuys, California, United States
Optumcare Clinical Trials,LLC-Golden
Colorado Springs, Colorado, United States
FEME Medical LLC
Washington D.C., District of Columbia, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
AGA Clinical Trial
Hialeah, Florida, United States
Bioclinical Research Alliance
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Optimal Research Sites
Orange City, Florida, United States
Center for Diab,Obes & Metab
Pembroke Pines, Florida, United States
Javara Inc. / Privia Medical Group Georgia LLC
Fayetteville, Georgia, United States
Clinical Invest Special_Gurnee
Gurnee, Illinois, United States
Iowa Diabetes & Endo Res Ctr
West Des Moines, Iowa, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.
TrialsTirzepatide trial dashboard →DatabaseTirzepatide database entry →ResearchTirzepatide research guide →TrialsSemaglutide trial dashboard →DatabaseSemaglutide database entry →ResearchSemaglutide research guide →TrialsCagrilintide trial dashboard →DatabaseCagrilintide database entry →TrialsGlucagon trial dashboard →DatabaseGlucagon database entry →ResearchGlucagon research guide →